EPA (Environmental Protection Agency)
2 records
EPA TRI: SIEMENS HEALTHCARE DIAGNOSTICS
TRI facility in EAST WALPOLE, MA (NORFOLK County)
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EPA TRI: SIEMENS HEALTHCARE DIAGNOSTICS INC
TRI facility in ELKHART, IN (ELKHART County)
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fda
522 records
FDA Device Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11
2026-04-08
Class II — A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by ...
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FDA Device Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
2026-03-11
Class II — Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL a...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20250813
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing | Product: epoc BGEM BUN Test Card [25pk]. Materi...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20250806
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive | Product: RAPIDPoint 500 Systems Wash/Waste Cart...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20250101
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) | Product: Magnesium Flex reagent cartridge, 360 ...
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FDA Device Recall: Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catal
2025-11-19
Class II — The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combinat...
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FDA Device Recall: 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj
2025-11-19
Class II — The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combinat...
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FDA Device Recall: IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038610
2025-11-19
Class II — The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combinat...
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FDA Device Recall: epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
2025-08-13
Class II — Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bia...
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FDA Device Recall: RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
2025-08-06
Class II — Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, ...
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FDA Device Recall: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
2025-07-09
Class II — Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
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FDA Device Recall: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
2025-07-09
Class II — Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
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FDA Device Recall: Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
2025-06-04
Class II — Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability result...
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FDA Device Recall: ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
2025-06-04
Class II — Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability result...
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FDA Device Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Mate
2025-05-07
Class II — The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
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FDA Device Recall: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11
2025-04-16
Class II — Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
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FDA Device Recall: Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Mate
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low m...
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FDA Device Recall: epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Nu
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect pa...
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FDA Device Recall: epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Nu
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect pa...
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FDA Device Recall: epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect pa...
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FDA Device Recall: epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Nu
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect pa...
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FDA Device Recall: epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Nu
2025-01-01
Class II — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect pa...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20240918
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greate | Product: Atellica IM CA 19-9 (50 Test)-In vitro...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20240918
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. | Product: Atellica CH Urinary/Cerebrospinal Fluid...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20240918
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There | Product: Dimension Vista¿ Total Bilirubin (TBIL...
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FDA Device Recall: Atellica CI Analyzer. Catalog Numbers: 10947347.
2024-12-11
Class II — Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displ...
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FDA Device Recall: Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitativ
2024-12-11
Class II — Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
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FDA Device Recall: IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Nu
2024-11-20
Class II — The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
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FDA Device Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
2024-11-13
Class II — Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maxim...
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FDA Device Recall: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Te
2024-10-09
Class II — Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
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FDA Device Recall: Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitat
2024-09-25
Class II — Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Us...
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FDA Device Recall: ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quan
2024-09-25
Class II — Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Us...
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FDA Device Recall: Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measur
2024-09-18
Class II — Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample populatio...
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FDA Device Recall: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number
2024-09-18
Class II — The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
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FDA Device Recall: Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material
2024-09-18
Class II — During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line whi...
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FDA Device Recall: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Num
2024-09-18
Class II — The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
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FDA Device Recall: ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative meas
2024-09-18
Class II — Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample populatio...
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FDA Device Recall: Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative
2024-09-18
Class II — Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample populatio...
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FDA Device Recall: ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative mea
2024-09-18
Class II — Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample populatio...
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FDA Device Recall: Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Mater
2024-07-03
Class II — Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary ...
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FDA Device Recall: Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ser
2024-04-24
Class II — Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ra...
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FDA Device Recall: Atellica IM Erythropoietin (EPO) Assay (100 Test)
2024-03-20
Class II — Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proport...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20230906
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. | Product: epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20230906
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (M | Product: Atellica CH Triglycerides (concentrate...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20230906
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calib | Product: Atellica CH Gamma-Glutamyl Transferase...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20230830
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depr | Product: ADVIA Chemistry Urinary/Cerebrospinal ...
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FDA Device Recall: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in
2023-12-27
Class II — RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a dela...
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FDA Device Recall: epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 114
2023-12-27
Class II — Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the result...
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FDA Device Recall: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in
2023-12-27
Class II — RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a dela...
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FDA Device Recall: RAPIDPOINT 500 Blood Gas System
2023-12-06
Class II — There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500...
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FDA Device Recall: RAPIDPOINT 500e Blood Gas System
2023-12-06
Class II — There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500...
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FDA Device Recall: ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tes
2023-10-11
Class II — There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary we...
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FDA Device Recall: epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor
2023-09-06
Class II — There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
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FDA Device Recall: Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantita
2023-09-06
Class II — Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
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FDA Device Recall: Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitat
2023-09-06
Class II — Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH To...
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FDA Device Recall: Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative dete
2023-09-06
Class II — Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH ...
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FDA Device Recall: Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative deter
2023-09-06
Class II — Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
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FDA Device Recall: Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determ
2023-09-06
Class II — Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
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FDA Device Recall: Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative dete
2023-09-06
Class II — Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH T...
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FDA Device Recall: Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determ
2023-09-06
Class II — Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH T...
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FDA Device Recall: Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determi
2023-09-06
Class II — Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
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FDA Device Recall: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1131
2023-08-30
Class II — There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed wh...
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FDA Device Recall: Aptio Automation Storage and Retrieval Module (SRM)
2023-07-12
Class II — A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in t...
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FDA Device Recall: Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrat
2023-05-31
Class II — Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
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FDA Device Recall: Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995
2023-05-10
Class II — There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
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FDA Device Recall: ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 25
2023-05-10
Class II — There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
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FDA Device Recall: epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc
2023-03-15
Class II — pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
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FDA Device Recall: Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative
2023-03-01
Class II — Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
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FDA Device Recall: ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnosti
2023-03-01
Class II — Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg ...
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FDA Device Recall: Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantit
2023-03-01
Class II — Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
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FDA Device Recall: IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE
2023-01-18
Class II — Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20220615
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results | Product: Atellica IM 1300 Analyzer - automated, immunoassay analyzer desi...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20220511
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | Product: ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the ...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20220511
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results | Product: ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use i...
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FDA Device Recall: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemen
2022-12-21
Class II — Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
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FDA Device Recall: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. S
2022-12-21
Class II — Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
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FDA Device Recall: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartrid
2022-10-26
Class II — Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a false...
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FDA Device Recall: Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic
2022-10-26
Class II — Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lea...
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FDA Device Recall: N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD
2022-10-26
Class II — N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
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FDA Device Recall: N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IV
2022-10-26
Class II — N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
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FDA Device Recall: Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for th
2022-09-07
Class II — Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
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FDA Device Recall: Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative
2022-08-10
Class II — Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an ir...
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FDA Device Recall: epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quant
2022-07-20
Class II — Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
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FDA Device Recall: Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardia
2022-07-13
Class II — Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for m...
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FDA Device Recall: Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac
2022-07-13
Class II — Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for m...
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FDA Device Recall: Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform
2022-06-15
Class II — Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
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FDA Device Recall: Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform
2022-06-15
Class II — Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
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FDA Device Recall: ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the qua
2022-05-11
Class II — Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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FDA Device Recall: ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in t
2022-05-11
Class II — Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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FDA Device Recall: Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the
2022-05-11
Class II — Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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FDA Device Recall: Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quant
2022-05-11
Class II — Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
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FDA Device Recall: IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L
2022-05-04
Class II — Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
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FDA Device Recall: Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
2022-04-20
Class II — Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
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FDA Device Recall: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
2022-04-20
Class II — Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
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FDA Device Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1109
2022-04-20
Class II — Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
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FDA Device Recall: Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 104451
2022-04-06
Class II — Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous...
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FDA Device Recall: Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the
2022-01-05
Class II — ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 ...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20211208
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | Product: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedure...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20210623
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results | Product: Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) ...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20210421
Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Product: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20210421
Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Product: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analy
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20210317
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dime | Product: Dimension Vista HDLC - colorimetric me...
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FDA Device Recall: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual ana
2021-12-08
Class II — Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
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FDA Device Recall: Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual ana
2021-12-08
Class II — Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
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FDA Device Recall: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
2021-11-10
Class II — Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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FDA Device Recall: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
2021-11-10
Class II — Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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FDA Device Recall: Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Cent
2021-11-10
Class II — The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test ...
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FDA Device Recall: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
2021-11-03
Class II — The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depress...
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FDA Device Recall: Atellica IM 1600 Analyzer, SMN 11066000
2021-10-27
Class II — Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea...
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FDA Device Recall: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the qua
2021-09-15
Class II — Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot...
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FDA Device Recall: Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic us
2021-09-15
Class II — Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot...
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FDA Device Recall: Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic test
2021-07-14
Class II — Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking o...
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FDA Device Recall: The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034
2021-07-14
Class II — ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection se...
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FDA Device Recall: Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material N
2021-06-23
Class II — Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
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FDA Device Recall: Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnosti
2021-06-02
Class II — Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing w...
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FDA Device Recall: BCS XP System: Multipurpose system for in vitro coagulation studies. Product cod
2021-04-28
Class II — Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
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FDA Device Recall: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hem
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automa
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hema
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hema
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology an
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hemat
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology ana
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated he
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology anal
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology anal
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology ana
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology
2021-04-21
Class II — Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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FDA Device Recall: Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
2021-03-24
Class II — Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Inter...
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FDA Device Recall: Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used a
2021-03-17
Class II — Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Ch...
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FDA Device Recall: Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. P
2021-01-20
Class II — Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
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FDA Device Recall: Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Pr
2021-01-20
Class II — Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
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FDA Device Recall: Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. P
2021-01-20
Class II — Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20201021
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to | Product: ADVIA Chemistry Systems-Fructosamine (...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20200617
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing | Product: ADVIA Chemistry Fructosamine Reagent (...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20200325
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician | Product: IMMULITE 2000 Systems E2 Estradiol Cat...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20200226
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference h | Product: Dimension Vista Enzymatic Creatinine (...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20200129
Homocysteine Assay May Cause Elevated Results in the Folate Assay | Product: Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:1031030
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FDA Device Recall: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro
2020-12-30
Class II — Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (wit...
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FDA Device Recall: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro dia
2020-12-30
Class II — Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (wit...
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FDA Device Recall: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In
2020-10-28
Class II — Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U...
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FDA Device Recall: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the q
2020-10-21
Class II — Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic...
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FDA Device Recall: Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quant
2020-10-21
Class II — Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic...
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FDA Device Recall: Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative test
2020-09-23
Class II — Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia...
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FDA Device Recall: Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In
2020-09-09
Class II — Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
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FDA Device Recall: DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZ
2020-08-12
Class II — If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analy...
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FDA Device Recall: (1) CentraLink Data Management System software version 16.0.2 Siemens Material N
2020-07-08
Class II — Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but ...
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FDA Device Recall: Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #1038
2020-07-08
Class II — Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazar...
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FDA Device Recall: ADVIA Chemistry Calibrator
2020-07-01
Class II — Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
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FDA Device Recall: Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630
2020-07-01
Class II — Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
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FDA Device Recall: RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Mate
2020-07-01
Class II — The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
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FDA Device Recall: ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, U
2020-06-17
Class II — The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
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FDA Device Recall: Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number
2020-06-17
Class II — The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
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FDA Device Recall: Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI N
2020-06-17
Class II — The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
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FDA Device Recall: Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 008
2020-06-17
Class II — The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
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FDA Device Recall: Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version
2020-05-06
Class II — Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the as...
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FDA Device Recall: ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70
2020-04-01
Class II — Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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FDA Device Recall: Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the d
2020-04-01
Class II — Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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FDA Device Recall: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of
2020-04-01
Class II — Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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FDA Device Recall: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE
2020-03-25
Class II — Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopa...
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FDA Device Recall: IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Pro
2020-03-25
Class II — Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopa...
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FDA Device Recall: Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Ve
2020-03-11
Class II — A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
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FDA Device Recall: Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Ve
2020-03-11
Class II — A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
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FDA Device Recall: Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
2020-02-26
Class II — There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinin...
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FDA Device Recall: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrat
2020-02-26
Class II — Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
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FDA Device Recall: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usa
2020-02-26
Class II — Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.
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FDA Device Recall: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
2020-02-26
Class II — There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinin...
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FDA Device Recall: Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
2020-02-26
Class II — There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinin...
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FDA Device Recall: Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1
2020-02-05
Class II — On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodiu...
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FDA Device Recall: Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red bloo
2020-01-29
Class II — Homocysteine Assay May Cause Elevated Results in the Folate Assay
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FDA Device Recall: Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red bl
2020-01-29
Class II — Homocysteine Assay May Cause Elevated Results in the Folate Assay
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FDA Device Recall: Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in seru
2020-01-29
Class II — Homocysteine Assay May Cause Elevated Results in the Folate Assay
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20191030
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 | Product: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20190710
A steady upward trend in blank (u) absorbance was observed | Product: ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 -
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20190508
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when com | Product: SiemensADVIA Centaur aTG (500 test kit...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20190206
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atell | Product: Atellica CH 930 Analyzer. In vitro di...
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FDA Device Recall: Atellica CH 930 Analyzer
2019-12-04
Class II — Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
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FDA Device Recall: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Nu
2019-10-30
Class II — Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
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FDA Device Recall: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material N
2019-10-30
Class II — Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
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FDA Device Recall: Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Te
2019-10-02
Class II — Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCC...
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FDA Device Recall: IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
2019-08-28
Class II — There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone su...
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FDA Device Recall: Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: T
2019-08-14
Class II — Negative Bias with Lot EA9227.
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FDA Device Recall: Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro dia
2019-08-07
Class II — Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
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FDA Device Recall: ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Numbe
2019-07-10
Class II — A steady upward trend in blank (u) absorbance was observed
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FDA Device Recall: Atellica IM 1600 Analyzer, Material Number 11066000
2019-05-15
Class II — There were multiple issues identified in the system software which required an update.
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FDA Device Recall: SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
2019-05-08
Class II — Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World H...
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FDA Device Recall: Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
2019-05-08
Class II — Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World H...
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FDA Device Recall: Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
2019-05-08
Class II — Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World H...
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FDA Device Recall: syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clini
2019-04-24
Class II — Software Issues.
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FDA Device Recall: Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Sie
2019-02-06
Class II — Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample...
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FDA Device Recall: Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Si
2019-02-06
Class II — Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample...
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FDA Device Recall: Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - P
2019-02-06
Class II — Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181226
Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. | Product: Dimension Vista 500, model no. 1028447...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181121
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. | Product: Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product ...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181031
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. | Product: APTIO 15000 REFRIGERATED STORAGE MODULE
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181031
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. | Product: APTIO RACK INPUT MODULE
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181031
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. | Product: STREAMLAB CORE UNIT / LYNX WITH IOM
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181024
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended w | Product: Atellica Sample Handler Prime (SMN 110...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20181024
A potential bias was identified with certain kits compared to the internal standards. | Product: Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for e
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20181024
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended w | Product: Atellica IM 1600 Analyzer (SMN 1106600...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimens | Product: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimens | Product: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimens | Product: IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA1...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sul | Product: ADVIA Alanine Aminotransferase (ALT) r...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimens | Product: IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA1...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20180516
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L | Product: ADVIA Centaur¿ DHEA-SO4
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FDA Device Recall: Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended t
2018-12-26
Class II — Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator...
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FDA Device Recall: Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended
2018-12-26
Class II — Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator...
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FDA Device Recall: Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro
2018-12-05
Class II — Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette i...
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FDA Device Recall: Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product
2018-11-21
Class II — There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
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FDA Device Recall: Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage:
2018-11-21
Class II — There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
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FDA Device Recall: Dimension Thermal Chamber Motor Cable located in the following models: Model/UD
2018-11-14
Class II — Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result i...
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FDA Device Recall: APTIO 15000 REFRIGERATED STORAGE MODULE
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: APTIO RACK INPUT MODULE
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: STREAMLAB CORE UNIT / LYNX WITH IOM
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: APTIO INPUT/OUTPUT MODULE
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: STREAMLAB - REFRIGERATED STORAGE MODULE 9000
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: STREAMLAB - REFRIGERATED STORAGE MODULE 15000
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: APTIO RACK OUTPUT MODULE
2018-10-31
Class II — The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Device Recall: Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a mul
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro
2018-10-24
Class II — A potential bias was identified with certain kits compared to the internal standards.
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FDA Device Recall: Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-com
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro
2018-10-24
Class II — A potential bias was identified with certain kits compared to the internal standards.
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FDA Device Recall: Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: Fo
2018-10-24
Class II — A potential bias was identified with certain kits compared to the internal standards.
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FDA Device Recall: Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a mul
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-com
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-c
2018-10-24
Class II — Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Anc...
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FDA Device Recall: RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is po
2018-09-05
Class II — Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicate...
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FDA Device Recall: RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is poi
2018-09-05
Class II — Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicate...
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FDA Device Recall: RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Dev
2018-09-05
Class II — Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicate...
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FDA Device Recall: Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
2018-07-25
Class II — The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is a...
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FDA Device Recall: Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
2018-07-25
Class II — The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is a...
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FDA Device Recall: Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoa
2018-06-20
Class II — The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing sep...
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FDA Device Recall: Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme im
2018-06-20
Class II — The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing sep...
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FDA Device Recall: ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVI
2018-06-13
Class II — Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
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FDA Device Recall: Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylli
2018-06-06
Class II — Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient...
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FDA Device Recall: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to m
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: ADVIA Centaur¿ DHEA-SO4
2018-05-16
Class II — The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cy...
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FDA Device Recall: Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Sie
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Hea
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to q
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
2018-05-16
Class II — The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cy...
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FDA Device Recall: ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determi
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Hea
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens He
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339)
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: ADVIA Centaur¿ HBc IgM
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: IMMULITE ¿ /IMMULITE ¿ 1000 CEA
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/1
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
2018-05-16
Class II — The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cy...
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FDA Device Recall: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
2018-05-16
Class II — Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADV...
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FDA Device Recall: ADVIA Centaur¿ Cyclosporine
2018-05-16
Class II — The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cy...
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FDA Device Recall: Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: S
2018-05-16
Class II — Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or ...
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FDA Device Recall: Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SM
2018-05-09
Class II — May produce erroneously low results from specific well sets.
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FDA Device Recall: Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of
2018-05-09
Class II — When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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FDA Device Recall: Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
2018-05-09
Class II — When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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FDA Device Recall: Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic test
2018-05-09
Class II — When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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FDA Device Recall: ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests);
2018-05-02
Class II — Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
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FDA Device Recall: Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitr
2018-04-04
Class II — An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Es...
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FDA Device Recall: BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and
2018-03-07
Class II — The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results...
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FDA Device Recall: ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quanti
2018-03-07
Class II — Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
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FDA Device Recall: ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material N
2018-02-14
Class II — Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20171206
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, | Product: Dimension Vista Protein 1 Control M, P...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20170517
Potential Patient Demographic Error with Blank Patient ID Field | Product: RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or lab
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20170412
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems | Product: Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pac...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class III
20170412
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) | Product: ADVIA Chemistry Enzyme 2 Calibrator, m...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20170315
DHEA-S causes falsely elevated progesterone results. | Product: IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 1038
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20170208
Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0 | Product: IMMULITE/IMMULITE 1000 Systems, Third ...
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FDA Device Recall: Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN)
2017-12-06
Class II — Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ...
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FDA Device Recall: Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN)
2017-12-06
Class II — Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ...
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FDA Device Recall: Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
2017-06-28
Class II — The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DI...
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FDA Device Recall: ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223014
2017-05-24
Class II — Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. O...
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FDA Device Recall: ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Num
2017-05-24
Class II — Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. O...
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FDA Device Recall: RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a
2017-05-17
Class II — Potential Patient Demographic Error with Blank Patient ID Field
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FDA Device Recall: Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests
2017-04-12
Class II — Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
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FDA Device Recall: ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: As
2017-04-12
Class III — Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concent...
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FDA Device Recall: ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2
2017-03-29
Class II — Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the an...
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FDA Device Recall: IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Nu
2017-03-15
Class II — DHEA-S causes falsely elevated progesterone results.
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FDA Device Recall: IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Nu
2017-03-15
Class II — DHEA-S causes falsely elevated progesterone results.
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FDA Device Recall: Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Numbe
2017-03-15
Class II — DHEA-S causes falsely elevated progesterone results.
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FDA Device Recall: ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Produc
2017-03-15
Class II — DHEA-S causes falsely elevated progesterone results.
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FDA Device Recall: Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028590
2017-03-08
Class II — Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur...
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FDA Device Recall: Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028590
2017-03-08
Class II — Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur...
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FDA Device Recall: Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 1028590
2017-03-08
Class II — Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur...
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FDA Device Recall: The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Amino
2017-02-22
Class III — Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples...
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FDA Device Recall: The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of
2017-02-22
Class III — Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient sa...
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FDA Device Recall: Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is
2017-02-15
Class II — Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim...
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FDA Device Recall: IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1,
2017-02-08
Class II — Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20161123
CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instruc | Product: ADVIA Centaur CA 19-9 Assay (50 test k...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20160921
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though | Product: Siemens RAPIDPoint 405 Blood Gas Analy...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20160914
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical | Product: ADVIA Centaur¿ PSA Assay; Cat No. 0657...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20160518
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 1534 | Product: Dimension Vista Blood Urea Nitrogen (B...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20160518
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reactio | Product: Dimension Assays: Triglycerides (TGL)
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20160330
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Product: IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20160330
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Product: Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757
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FDA Device Recall: IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalo
2016-12-28
Class II — Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
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FDA Device Recall: ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
2016-12-14
Class II — Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hem...
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FDA Device Recall: Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is a
2016-11-30
Class II — Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.
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FDA Device Recall: ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and A
2016-11-23
Class II — CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.
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FDA Device Recall: Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of A
2016-11-23
Class II — Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on pa...
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FDA Device Recall: ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and A
2016-11-23
Class II — CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.
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FDA Device Recall: Dimension Vista IRON Flex reagent cartridges
2016-11-23
Class III — Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for...
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FDA Device Recall: Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
2016-11-23
Class II — Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
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FDA Device Recall: Dimension IRON Flex reagent cartridges
2016-11-23
Class III — Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for...
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FDA Device Recall: Aptio Automation Modules
2016-11-23
Class II — Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
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FDA Device Recall: Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
2016-11-23
Class II — Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
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FDA Device Recall: IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) -
2016-11-02
Class II — Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and ab...
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FDA Device Recall: SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for
2016-10-19
Class II — Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM ass...
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FDA Device Recall: ADVIA Centaur XPT Immunoassay System
2016-10-19
Class II — The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. ...
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FDA Device Recall: SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKR
2016-10-19
Class II — Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM ass...
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FDA Device Recall: Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011
2016-10-12
Class II — Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
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FDA Device Recall: Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating
2016-10-05
Class II — Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
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FDA Device Recall: Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN):
2016-09-21
Class II — There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for ...
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FDA Device Recall: RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1047
2016-09-21
Class II — There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for ...
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FDA Device Recall: RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1049
2016-09-21
Class II — There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for ...
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FDA Device Recall: Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 104
2016-09-21
Class II — There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for ...
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FDA Device Recall: ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN
2016-09-14
Class II — Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatect...
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FDA Device Recall: ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Ch
2016-09-07
Class II — Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue af...
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FDA Device Recall: ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro
2016-08-03
Class II — Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (...
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FDA Device Recall: Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1
2016-06-08
Class II — Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimensi...
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FDA Device Recall: Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1
2016-06-08
Class II — Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimensi...
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FDA Device Recall: ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.
2016-05-25
Class II — Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of t...
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FDA Device Recall: Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN meth
2016-05-18
Class II — Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/...
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FDA Device Recall: Dimension Assays: Triglycerides (TGL)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF
2016-05-18
Class II — Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB606...
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FDA Device Recall: Dimension Assays: ENZYMATIC CREATININE
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Dimension Assays: Direct HDL Cholesterol (AHDL)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Dimension Vista Assays: Triglycerides (TRIG)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Dimension Vista Assays: Uric Acid (URCA)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
2016-05-18
Class II — Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that f...
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FDA Device Recall: ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The
2016-04-27
Class II — Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulo...
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FDA Device Recall: IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26,
2016-03-30
Class II — The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
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FDA Device Recall: Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889
2016-03-30
Class II — The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
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FDA Device Recall: IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 S
2016-03-30
Class II — The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
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FDA Device Recall: Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 104890
2016-03-30
Class II — The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
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FDA Device Recall: Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabil
2016-03-09
Class II — Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vis...
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FDA Device Recall: BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in v
2016-03-02
Class II — False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only w...
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FDA Device Recall: BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitr
2016-03-02
Class II — False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only w...
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FDA Device Recall: ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical ch
2016-02-10
Class II — Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System...
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FDA Device Recall: Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used
2016-01-13
Class II — Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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FDA Device Recall: Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be us
2016-01-13
Class II — Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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FDA Device Recall: Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vit
2016-01-13
Class II — Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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FDA Device Recall: Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro di
2016-01-13
Class II — Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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FDA Device Recall: Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative me
2016-01-13
Class II — Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20150930
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | Product: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20150916
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for | Product: Dimension¿ CREA (Creatinine) and Dime...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20150429
Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Ch | Product: ADVIA Chemistry Lipase Reagent , Catal...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20150401
Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 ( | Product: ADVIA Chemistry Systems Drug Calibrato...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20150318
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration ex | Product: RAPIDPoint 500 Blood Gas Analyzer; Sie...
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FDA Device Recall: Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: T
2015-12-30
Class II — Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination blo...
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FDA Device Recall: Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number
2015-12-30
Class II — Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. Thi...
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FDA Device Recall: Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 1
2015-12-02
Class II — Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ...
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FDA Device Recall: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 1
2015-09-30
Class II — RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
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FDA Device Recall: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 1
2015-09-30
Class II — RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
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FDA Device Recall: Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA m
2015-09-16
Class II — Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL...
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FDA Device Recall: ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used t
2015-09-16
Class II — Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
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FDA Device Recall: Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Us
2015-09-02
Class II — customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potent...
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FDA Device Recall: ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quant
2015-08-26
Class II — A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
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FDA Device Recall: EasyLink Data Management System; a clinical data management system that assists
2015-07-08
Class II — System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, an...
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FDA Device Recall: CentraLink" Data Management System; software is a network solution provider and
2015-07-08
Class II — Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimensio...
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FDA Device Recall: The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of
2015-07-08
Class II — D50 and D51 diagnostic error codes are not functional.
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FDA Device Recall: IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40
2015-07-01
Class II — IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the p...
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FDA Device Recall: Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with p
2015-06-10
Class II — Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recover...
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FDA Device Recall: IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of
2015-05-27
Class II — IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce...
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FDA Device Recall: Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimen
2015-05-20
Class II — Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration...
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FDA Device Recall: ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
2015-04-29
Class II — Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when run...
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FDA Device Recall: ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the ca
2015-04-01
Class II — Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) as...
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FDA Device Recall: N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of I
2015-03-25
Class III — Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.
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FDA Device Recall: RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855,
2015-03-18
Class II — Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of gre...
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FDA Device Recall: Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use w
2015-03-18
Class II — Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
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FDA Device Recall: RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.
2015-03-18
Class II — Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of gre...
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FDA Device Recall: Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with
2015-03-18
Class II — Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
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FDA Device Recall: RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.
2015-03-18
Class II — Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of gre...
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FDA Device Recall: ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog
2015-03-11
Class II — ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
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FDA Device Recall: ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Cata
2015-03-11
Class II — ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
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FDA Device Recall: ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog
2015-03-11
Class II — ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
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FDA Device Recall: ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in
2015-01-21
Class II — Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated res...
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FDA Device Recall: Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in
2015-01-14
Class II — Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed u...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20141231
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. | Product: ADVIA Centaur (including refurbished) Professional use in a...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20141105
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA | Product: ADVIA Centaur Calibrator C-Used with t...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20141105
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA | Product: ADVIA Centaur Calibrator C-Used with t...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20141105
Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive o | Product: siemens Dimension¿ Phenytoin Flex¿ Rea...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20140604
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin | Product: ADVIA Centaur Systems VitD Total 100 t...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class III
20140514
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Product: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
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FDA Recall: Siemens Healthcare Diagnostics — Class II
20140507
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. | Product: IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1...
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FDA Device Recall: ADVIA Centaur (including refurbished) Professional use in a laboratory for in
2014-12-31
Class II — A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
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FDA Device Recall: Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent L
2014-12-31
Class II — Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with sim...
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FDA Device Recall: ADVIA Centaur XP Immunoassay System (including refurbished) Professional use
2014-12-31
Class II — A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
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FDA Device Recall: Turbo Troponin I For in vitro diagnostic use for the quantitative measurement
2014-12-24
Class II recall by Siemens Healthcare Diagnostics, Inc.
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FDA Device Recall: Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) F
2014-12-03
Class II — Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the Nati...
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FDA Device Recall: ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (Fo
2014-11-26
Class III — Stability of the ADVIA Centaur Cleaning Solution is not assured
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FDA Device Recall: Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material
2014-11-19
Class I — An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
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FDA Device Recall: Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid p
2014-11-19
Class I — An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
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FDA Device Recall: IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMU
2014-11-19
Class III — A typographical error regarding the expiration date was identified in the control module instructions for use.
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FDA Device Recall: ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADV
2014-11-05
Class II — Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
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FDA Device Recall: ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADV
2014-11-05
Class II — Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
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FDA Device Recall: siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on t
2014-11-05
Class II — Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across ...
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FDA Device Recall: ADVIA Centaur XP Immunoassay System (including refurbished units), This syst
2014-10-08
Class II — The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremel...
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FDA Device Recall: ADVIA Centaur Immunoassay System (including refurbished units), This system
2014-10-08
Class II — The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremel...
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FDA Device Recall: Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitr
2014-10-08
Class II — Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® ...
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FDA Device Recall: ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (S
2014-09-24
Class II — The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far...
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FDA Device Recall: ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, R
2014-09-24
Class II — The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality c...
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FDA Device Recall: Siemens CentraLink Data Management System, software version 14. The CentraL
2014-09-24
Class II — Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executi...
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FDA Device Recall: ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN)
2014-09-24
Class II — The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far...
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FDA Device Recall: Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices in
2014-09-03
Class II — The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
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FDA Device Recall: RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement
2014-07-30
Class II — RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
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FDA Device Recall: MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument
2014-07-09
Class II — Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for ...
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FDA Device Recall: ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN
2014-07-09
Class II — The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
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FDA Device Recall: Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed
2014-07-02
Class II — Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contribut...
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FDA Device Recall: Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur
2014-07-02
Class II — Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
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FDA Device Recall: Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Tro
2014-07-02
Class II — Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
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FDA Device Recall: Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor rep
2014-06-18
Class II — A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
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FDA Device Recall: ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201.
2014-06-04
Class II — Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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FDA Device Recall: ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021.
2014-06-04
Class II — Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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FDA Device Recall: ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 0649108
2014-06-04
Class II — Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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FDA Device Recall: ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 103788
2014-06-04
Class II — Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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FDA Device Recall: ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072
2014-06-04
Class II — Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
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FDA Device Recall: Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnost
2014-05-28
Class II — A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been obser...
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FDA Device Recall: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10
2014-05-14
Class III — Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
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FDA Device Recall: Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No
2014-05-14
Class II — Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
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FDA Device Recall: IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD ---
2014-05-07
Class II — Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
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FDA Device Recall: IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 1
2014-05-07
Class II — Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedi...
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FDA Device Recall: ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 Fo
2014-02-12
Class II — ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calib...
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FDA Device Recall: ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 F
2014-02-12
Class II — ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calib...
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FDA Device Recall: T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1038
2014-02-05
Class II — Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above...
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FDA Device Recall: User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vis
2014-02-05
Class II — When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory...
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FDA Device Recall: T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Numb
2014-02-05
Class II — Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above...
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FDA Device Recall: Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic te
2014-01-29
Class II — Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
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FDA Device Recall: HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for t
2014-01-15
Class II — Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
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FDA Device Recall: Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052
2014-01-01
Class II — Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD2303...
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FDA Recall: Siemens Healthcare Diagnostics — Class II
20131127
Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 180 | Product: Siemens Chemistry Calibrator (CAL) use...
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FDA Recall: Siemens Healthcare Diagnostics Inc — Class II
20131106
RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demogra | Product: Siemens RAPIDLab¿ 1265 system blood ...
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FDA Recall: Siemens Healthcare Diagnostics — Class II
20131023
Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possibl | Product: ADVIA 2120/2120i Hematology Systems wi...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class I
20130918
Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Neg | Product: Microscan Synergies Plus Negative Urin...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class I
20130918
Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Neg | Product: Microscan Synergies Plus Negative Urin...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class I
20130918
Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Neg | Product: Microscan Synergies Plus Negative Brea...
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FDA Recall: Siemens Healthcare Diagnostics — Class III
20130116
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA | Product: Immunoradiometric assay. Device is ...
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FDA Device Recall: Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in
2013-12-25
Class II — Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
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FDA Device Recall: Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method i
2013-12-25
Class II — Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
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FDA Device Recall: Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limi
2013-12-11
Class II — There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500...
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FDA Device Recall: syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolid
2013-12-11
Class II — Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto...
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FDA Device Recall: Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubi
2013-11-27
Class II — Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The Sys...
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FDA Device Recall: ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general a
2013-11-27
Class II — Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chem...
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FDA Device Recall: ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general a
2013-11-27
Class II — Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chem...
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FDA Device Recall: Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1
2013-11-06
Class II — RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could le...
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FDA Device Recall: Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These sys
2013-11-06
Class II — RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could le...
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FDA Device Recall: Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint
2013-11-06
Class II — RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could le...
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FDA Device Recall: ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10
2013-10-23
Class II — Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the ...
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FDA Device Recall: Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent
2013-10-23
Class II — Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
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FDA Device Recall: Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Sy
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroSca
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroS
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Produc
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usa
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergi
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitr
2013-09-18
Class II — Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
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FDA Device Recall: ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diag
2013-09-18
Class II — Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
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FDA Device Recall: Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Sy
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: Micro
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: M
2013-09-18
Class I — Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
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FDA Device Recall: ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL
2013-09-11
Class II — Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lo...
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FDA Device Recall: ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . Th
2013-09-04
Class II — The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the c...
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FDA Device Recall: PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numb
2013-09-04
Class II — Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Ge...
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FDA Device Recall: ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800
2013-08-21
Class III — Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.
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FDA Device Recall: IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 -
2013-08-14
Class II — A rare variant of TSH, identified in a small cluster of patients, is not detected.
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FDA Device Recall: Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Crea
2013-08-14
Class II — Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequenc...
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FDA Device Recall: ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491
2013-08-14
Class II — A rare variant of TSH, identified in a small cluster of patients, is not detected.
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FDA Device Recall: Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended t
2013-08-14
Class II — A rare variant of TSH, identified in a small cluster of patients, is not detected.
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FDA Device Recall: ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro d
2013-06-12
Class II — iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
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FDA Device Recall: ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361.
2013-06-12
Class II — iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
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FDA Device Recall: ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use
2013-06-12
Class II — iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
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FDA Device Recall: ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For us
2013-04-24
Class II — Negative bias in patient samples for Vitamin D
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FDA Device Recall: Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Inte
2013-04-10
Class III — Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investig...
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FDA Device Recall: Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended
2013-04-10
Class III — Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investig...
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FDA Device Recall: Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL
2013-04-03
Class III — Correlation slope bias and accuracy shift
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FDA Device Recall: Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR meth
2013-03-27
Class II — Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of th...
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FDA Device Recall: Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vi
2013-03-20
Class III — The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron...
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FDA Device Recall: Immunoradiometric assay. Device is an immunoradiometric assay designed for th
2013-01-16
Class III — The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 ...
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FDA Device Recall: Immunoradiometric assay.
2013-01-16
Class III — The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 ...
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FDA Device Recall: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Cata
2013-01-16
Class III — When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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FDA Device Recall: Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital As
2013-01-16
Class II — Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if ...
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FDA Device Recall: Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Che
2013-01-16
Class III — When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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FDA Device Recall: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Dis
2013-01-16
Class III — When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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FDA Device Recall: Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N C
2013-01-16
Class II — When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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FDA Device Recall: Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Ne
2013-01-16
Class III — When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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FDA Device Recall: Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R)
2013-01-16
Class III — Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20121219
Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, | Product: Siemens Healthcare ADVIA Centaur Folat...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class II
20121212
Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed | Product: Dimension Vista(R) IRON Flex(R) reagen...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20120912
Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for | Product: Siemens ADVIA Centaur Multi-Diluent 1 ...
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FDA Recall: Siemens Healthcare Diagnostics, Inc. — Class III
20120905
Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error me | Product: Siemens Stratus(R) CS Acute Care(TM) D...
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FDA Recall: Siemens Healthcare Diagnostics, Inc — Class II
20120829
Syphilis Assay Interference with HBsAg Assay | Product: Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product
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FDA Device Recall: Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100
2012-12-19
Class II — Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADV...
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FDA Device Recall: Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419
2012-12-19
Class II — Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADV...
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FDA Device Recall: Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379
2012-12-19
Class II — Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVI...
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FDA Device Recall: Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is
2012-12-12
Class II — Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron ...
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FDA Device Recall: Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50
2012-11-07
Class II — BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
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FDA Device Recall: Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital As
2012-10-17
Class II — Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 ...
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FDA Device Recall: ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prol
2012-09-26
Class III — ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
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FDA Device Recall: Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADV
2012-09-12
Class II — Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
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FDA Device Recall: Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058
2012-09-05
Class III — Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indi...
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FDA Device Recall: Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number
2012-08-29
Class II — Syphilis Assay Interference with HBsAg Assay
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FDA Device Recall: EasyLink Informatic System is included with the Dimension Vista System. The Dim
2012-08-29
Class II — When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions se...
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FDA Device Recall: Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Health
2012-08-15
Class II — Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and ...
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FDA Device Recall: Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086).
2012-08-15
Class III — Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay ...
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FDA Device Recall: Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 F
2012-07-04
Class II — Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concent...
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ny_corps
1 records
NY Corp: SIEMENS HEALTHCARE DIAGNOSTICS INC.
2008-05-13
FOREIGN BUSINESS CORPORATION | County: Westchester | Jurisdiction: California
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USASpending
2 records
Federal Award: SIEMENS HEALTHCARE DIAGNOSTICS INC. — $2,740,520
2021-09-28
BILLINGS AREA CLINICAL CHEMISTRY ANALYZERS CPT LEASING; BASE + (4) 1-YEAR OPTIONS; TOTAL EST. AMT. $3,182,198; BASE YEAR AMT. $636,439.60
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Federal Award: SIEMENS HEALTHCARE DIAGNOSTICS INC. — $1,421,510
2020-09-10
VENDOR SHALL PROVIDE TWO ATELLICA CH930 ANALYZERS AND TWO ATELLICA IM 1300 ANALYZERS FOR THE PHOENIX INDIAN MEDICAL CENTER (PIMC) LOCATED IN PHOENIX, ARIZONA.
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