Manufacturer

Biomerieux Inc

100 recalls in our database name Biomerieux Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 100

HighFDA (Devices)·Z-1236-2026·2026-02-11
VITEK 2 Gram-negative Susceptibility Cards Risk of False Antibiotic Resistance Results
Biomerieux is recalling VITEK 2 Gram-negative Susceptibility Cards due to potential quality control failures and false antibiotic resistance results. The cards are used in clinical laboratories for antibiotic susceptibility testing.
Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1464-2024·2024-05-01
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.
Product
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1201-2023·2023-03-08
Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0819-2023·2023-01-11
ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion
Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.
Product
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0875-2023·2023-01-11
FDA Recalls PPM Lombard TSA Culture Medium Due to Storage Temperature Exceedance
Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.
Product
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0789-2023·2023-01-11
Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions
Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.
Product
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0841-2023·2023-01-11
ETEST Clinical Ceftolozane/Tazobactam Antibiotic Susceptibility Test Recalled for Temperature Excursion
Biomerieux is recalling ETEST Clinical Ceftolozane/Tazobactam S30 diagnostic tests (batch 1009420460) due to storage temperature and time excursions. Product performance cannot be guaranteed, and test accuracy may be affected.
Product
ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2023·2023-01-11
Medical Device Test Kit Recalled Due to Storage Condition Exceedance
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.
Product
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0796-2023·2023-01-11
Measles Antibody Test Kits Recalled Due to Temperature Excursion
Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.
Product
VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2023·2023-01-11
FDA Recalls ETEST Ertapenem Antibiotic Susceptibility Test Due to Storage Damage
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Product
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0837-2023·2023-01-11
VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance
Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.
Product
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2023·2023-01-11
ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Product
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0829-2023·2023-01-11
Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation
Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.
Product
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0784-2023·2023-01-11
Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Product
API 20 E 25 STRIPS, CATALOG 20100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0838-2023·2023-01-11
Medical device test kit recalled due to storage temperature and time excursion
Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.
Product
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2023·2023-01-11
ETEST Antibiotic Susceptibility Test Kit Recalled for Storage Degradation
Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.
Product
ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0813-2023·2023-01-11
Culture Medium Recall Due to Temperature Excursion Affecting Product Performance
Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.
Product
PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0814-2023·2023-01-11
Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion
Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.
Product
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0828-2023·2023-01-11
ETEST Minocycline Susceptibility Test Affected by Storage Temperature Exceedance
Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.
Product
ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2023·2023-01-11
ETEST Amikacin Test Strips Recalled for Storage Condition Excursion
Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.
Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2023·2023-01-11
VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure
Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.
Product
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2023·2023-01-11
ETEST Clinical Eravacycline ERV test kit recalled for temperature storage excursion
Biomerieux is recalling ETEST Clinical Eravacycline ERV test kits nationwide after temperature and time storage conditions exceeded acceptable ranges, making product performance unreliable.
Product
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0831-2023·2023-01-11
ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.
Product
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0785-2023·2023-01-11
API 20 C AUX Diagnostic Strips Recalled Due to Storage Temperature Exceedance
Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.
Product
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0783-2023·2023-01-11
Listeria Detection Test Strips Recalled for Unreliable Performance
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
Product
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Category
Medical Device
Distribution
Distributed nationwide