co_sos
1 records
CO Business: BIOMERIEUX, INC.
1992-06-08
FPC | Status: Good Standing | Salt Lake City, UT
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fda
358 records
FDA Recall: Biomerieux Inc — Class II
20260211
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae spec | Product: VITEK 2 Gram-negative Susceptibility C...
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FDA Device Recall: VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o
2026-02-11
Class II — Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with ...
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FDA Device Recall: VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs0
2025-10-08
Class II — Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
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FDA Device Recall: VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial suscep
2024-05-01
Class I — Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for ...
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
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FDA Recall: Biomerieux Inc — Class II
20230111
As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Product: API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
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FDA Device Recall: MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connec
2023-03-08
Class II — For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results wh...
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FDA Device Recall: PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: API NIT1 NIT2 REAGENTS, CATALOG 70442
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Device Recall: ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
2023-01-11
Class II — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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FDA Recall: bioMerieux, Inc. — Class II
20220518
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-cor | Product: VITEK 2 Systems and VITEK 2 with MYLA.
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FDA Device Recall: VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
2022-10-05
Class II — Invalid calibrations (out of range high) while using the product.
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FDA Device Recall: VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.
2022-09-07
Class II — There are 7 reported software anomalies that may affect use of the device.
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FDA Device Recall: NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
2022-08-31
Class II — There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
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FDA Device Recall: VITEK 2 Systems and VITEK 2 with MYLA.
2022-05-18
Class II — Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potent...
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FDA Device Recall: API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitativ
2022-02-02
Class II — Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
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FDA Device Recall: VIDAS RUB IgG (RBG), REF 30226
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS FSH, REF 30407-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS SARS-COV-2 IgM, Ref 423833-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS Estradiol II, REF 30431-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS Lyme IgG II (LYM), REF 417401
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS PRG Progesterone, REF 30409-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Device Recall: VIDAS LH, REF 30406-01
2022-01-05
Class II — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the ...
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FDA Recall: BioMerieux SA — Class II
20210818
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. | Product: MYLA software. Used to manage microbiology test ...
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FDA Device Recall: API 50 CH, Model 50300
2021-11-24
Class II — There is potential to provide an incorrect organism identification.
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FDA Device Recall: MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
2021-10-20
Class II — Under certain conditions, there is a risk for a false negative result.
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FDA Device Recall: MYLA software. Used to manage microbiology test workflow from the reception of
2021-08-18
Class II — Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
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FDA Device Recall: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
2021-08-18
Class II — Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
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FDA Device Recall: VIDAS¿ CMV IgM 30 Tests
2021-04-21
Class II — bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
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FDA Device Recall: VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with th
2021-03-31
Class II — bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results...
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FDA Device Recall: The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK
2020-04-29
Class II — There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403...
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FDA Device Recall: Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of ins
2019-04-24
Class II — Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418...
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FDA Device Recall: VITEK 2 AST-N351 Test Kit
2019-02-27
Class II — False Positive ESBL Phenotype
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FDA Recall: bioMerieux, Inc. — Class II
20181226
The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial | Product: VITEK¿ 2 Systems Software Version 9.01...
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FDA Recall: bioMerieux, Inc. — Class II
20180926
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required | Product: VITEK(R) 2 AST-P655, For susceptibilit...
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FDA Recall: bioMerieux, Inc. — Class II
20180718
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could | Product: BioMerieux VIDAS System in combination...
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FDA Recall: BioMerieux SA — Class II
20180704
Invalid calibration with low calibrator S1 while using the product. | Product: VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use o
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FDA Recall: BioMerieux SA — Class II
20180620
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply | Product: The VITEK¿ 2 Gram Positive Susceptibil...
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FDA Device Recall: VITEK¿ 2 Systems Software Version 9.01 Update Kit.
2018-12-26
Class II — The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results wh...
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FDA Device Recall: VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these su
2018-12-26
Class II — False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
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FDA Device Recall: BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage:
2018-10-31
Class II — The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cell...
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FDA Device Recall: BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Us
2018-10-31
Class II — The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cell...
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FDA Device Recall: NucliSENS¿ Magnetic Extraction Reagents
2018-10-31
Class II — Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
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FDA Device Recall: VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococ
2018-09-26
Class II — Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistanc...
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FDA Device Recall: VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococ
2018-09-26
Class II — Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistanc...
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FDA Device Recall: bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for
2018-08-29
Class I — Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
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FDA Device Recall: VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an
2018-08-08
Class II — Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
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FDA Device Recall: BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Pro
2018-07-18
Class II — Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any...
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FDA Device Recall: VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA,
2018-07-04
Class II — Invalid calibration with low calibrator S1 while using the product.
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FDA Device Recall: The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITE
2018-06-20
Class II — A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distribut...
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FDA Device Recall: The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended
2018-06-20
Class II — A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distribut...
View Source
FDA Device Recall: VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS fam
2018-06-20
Class II — A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distribut...
View Source
FDA Device Recall: The VITEK 2 Gram-Positive identification card (GP) is intended for use with the
2018-06-20
Class II — A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distribut...
View Source
FDA Recall: Biomerieux Inc — Class II
20170927
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association wit | Product: VITEK(R) 2 GP, REF 21342, IVD, UDI 035...
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FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Streptococcus Susceptibi...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK 2 Bacillus identification card (...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Negative Susceptibility ...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Fungal Susceptibility c...
View Source
FDA Recall: Biomerieux Inc — Class II
20170621
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of pot | Product: VITEK¿ 2 Gram Positive Susceptibility ...
View Source
FDA Recall: BioMerieux SA — Class II
20170329
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. | Product: ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DO...
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FDA Recall: BioMerieux SA — Class II
20170329
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. | Product: ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone...
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FDA Recall: BioMerieux SA — Class I
20170125
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). Thi | Product: NucliSENS magnetic extraction reagents...
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FDA Device Recall: ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative techni
2017-12-27
Class II — QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resist...
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FDA Device Recall: VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2
2017-09-27
Class II — Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2...
View Source
FDA Device Recall: VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17
2017-09-06
Class II — Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to...
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FDA Device Recall: VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards d
2017-09-06
Class II — Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to...
View Source
FDA Device Recall: VITEK 2 Gram Negative test kits containing colistin (cs01n)
2017-08-02
Class II — The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference...
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FDA Device Recall: VIDAS Testosterone, Ref 30418
2017-07-19
Class II — Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
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FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards p
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N236), REF 413171, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N232), REF 413116, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N246), REF 413395, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N245), REF 413394, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N317), IVD, REF 417558, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N298), IVD, REF 416004, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN71), REF 413402, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N250), REF 413573, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N223), REF 413110, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per ca
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 card
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per c
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards
2017-06-21
Class II — The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
View Source
FDA Device Recall: ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quant
2017-05-24
Class II — False susceptible results
View Source
FDA Device Recall: ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-3
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-2
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-3
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016
2017-03-29
Class II — Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
View Source
FDA Device Recall: ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a
2017-03-01
Class II — Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
View Source
FDA Device Recall: NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product
2017-01-25
Class I — A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-...
View Source
FDA Device Recall: MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ e
2017-01-25
Class I — A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2...
View Source
FDA Recall: Biomerieux Inc — Class I
20160518
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. | Product: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit....
View Source
FDA Recall: bioMerieux, Inc. — Class II
20160210
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. | Product: BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/A...
View Source
FDA Recall: Biomerieux Inc — Class II
20160106
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. | Product: Granada Biphasic Broth The product is a selective medium for the sc...
View Source
FDA Device Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards
2016-05-18
Class I — Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
View Source
FDA Device Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/
2016-05-18
Class I — Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
View Source
FDA Device Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/
2016-05-18
Class I — Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
View Source
FDA Device Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/
2016-05-18
Class I — Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
View Source
FDA Device Recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/
2016-05-18
Class I — Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
View Source
FDA Device Recall: BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles
2016-02-10
Class II — Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
View Source
FDA Device Recall: Granada Biphasic Broth The product is a selective medium for the screening an
2016-01-06
Class II — FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
View Source
FDA Recall: bioMerieux, Inc. — Class II
20151223
MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patien | Product: MYLA CLINIC PATCH 3.2.0 CD Product ...
View Source
FDA Device Recall: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitativ
2015-12-30
Class I — Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
View Source
FDA Device Recall: Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative
2015-12-30
Class I — Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
View Source
FDA Device Recall: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitativ
2015-12-30
Class I — Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
View Source
FDA Device Recall: MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( M
2015-12-23
Class II — MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
View Source
FDA Device Recall: MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application
2015-12-23
Class II — MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
View Source
FDA Device Recall: MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer applica
2015-12-23
Class II — MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
View Source
FDA Device Recall: MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer applica
2015-12-23
Class II — MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
View Source
FDA Device Recall: MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ( M
2015-12-23
Class II — MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
View Source
FDA Device Recall: Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, I
2015-05-20
Class II — The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
View Source
FDA Device Recall: Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IV
2015-05-20
Class II — The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
View Source
FDA Device Recall: Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per con
2015-04-15
Class III — The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
View Source
FDA Device Recall: Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per con
2015-04-15
Class III — The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
View Source
FDA Device Recall: Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Test
2014-11-26
Class III — The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
View Source
FDA Device Recall: Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testi
2014-11-26
Class III — The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
View Source
FDA Device Recall: Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testi
2014-11-26
Class III — The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
View Source
FDA Device Recall: Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testi
2014-11-26
Class III — The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
View Source
FDA Device Recall: VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrument
2014-08-20
Class II — Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng...
View Source
FDA Device Recall: ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to re
2014-04-30
Class II — bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32...
View Source
FDA Device Recall: API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH
2014-04-30
Class II — bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32...
View Source
FDA Device Recall: FB Reagent (REF 70562). FB reagent is an additional test used for revealing t
2014-04-30
Class II — bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32...
View Source
FDA Device Recall: bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical
2014-03-19
Class II — The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" ...
View Source
FDA Recall: Biomerieux Inc — Class II
20130814
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During th | Product: bioMerieux Vitek 2 Systems Software ve...
View Source
FDA Recall: Biomerieux Inc — Class II
20130814
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During th | Product: bioMerieux Vitek 2 Systems Software ve...
View Source
FDA Recall: Biomerieux Inc — Class II
20130403
There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. | Product: VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC mo...
View Source
FDA Device Recall: chromID Salmonella Agar, Reference No. 43621. A selective isolation and diffe
2013-11-06
Class II — Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentia...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2
2013-08-14
Class II — A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx ...
View Source
FDA Device Recall: VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC m
2013-04-03
Class II — There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
View Source
FDA Device Recall: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. F
2013-04-03
Class II — The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
View Source
FDA Device Recall: VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC m
2013-04-03
Class II — There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
View Source
FDA Device Recall: VITEK 2 Compact computer system when equipped with the following Hewlett-Packard
2013-04-03
Class II — There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
View Source
FDA Recall: Biomerieux Inc — Class II
20121128
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Product: bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software...
View Source
FDA Recall: Biomerieux Inc — Class II
20121128
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Product: bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument softw...
View Source
FDA Recall: Biomerieux Inc — Class II
20121128
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Product: bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument softw...
View Source
FDA Recall: Biomerieux Inc — Class II
20121017
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. | Product: PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, ...
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument softw
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument softw
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument soft
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument so
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument so
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument soft
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument sof
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument soft
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument soft
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB u
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB updat
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrume
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument s
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument soft
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument so
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
View Source
FDA Device Recall: bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB
2012-11-28
Class II — The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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FDA Device Recall: PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham,
2012-10-17
Class II — The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
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lobbying
10 records
Lobbying Client: BIOMERIEUX, INC.
Lobbied by BGR GOVERNMENT AFFAIRS — Medical technology company
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Lobbying Client: BIOMERIEUX, INC.
Lobbied by BALLARD PARTNERS — Medical technology company
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Lobbying Client: BIOMERIEUX, INC.
Lobbied by GROUNDSWELL STRATEGY LLC — Biotechnology company
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Lobbying Client: BIOMERIEUX, INC.
Lobbied by BLUE STAR STRATEGIES LLC — biotechnology company
View Source
Lobbying Client: BIOMERIEUX, INC.
Lobbied by GROUNDSWELL STRATEGY LLC — Biotechnology company
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Lobbying Client: BIOMERIEUX, INC.
Lobbied by ALSTON & BIRD LLP — Global in vitro diagnostics company.
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Lobbying Client: BIOMERIEUX, INC.
Lobbied by GROUNDSWELL STRATEGY LLC — Biotechnology company
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ny_corps
1 records
NY Corp: BIOMERIEUX, INC.
1978-11-01
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Missouri
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USASpending
2 records
Federal Award: BIOMERIEUX INC — $1,216,476
2026-05-06
BPA, BIOMERIEUX, BIOFIRE PANEL REAGENTS, PIMC LABORATORY DEPT, BPA CALL 26F28007
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