The Recall Desk

Manufacturer

bioMerieux, Inc.

422 recalls in our database name bioMerieux, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
422
Critical
0
Severe
5
Most recent
2026-07-15

Of the 422 recalls from bioMerieux, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (1%) are Severe.

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 422

  • HighFDA (Devices)·Z-2715-2026·2026-07-15

    VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results

    Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.

    Product
    VITEK 2 AST-N447 TEST KIT Product reference 424620
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1236-2026·2026-02-11

    Susceptibility test cards recalled over false resistant antibiotic results

    bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.

    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
  • HighFDA (Devices)·Z-2671-2025·2025-10-08

    Antimicrobial susceptibility test cards recalled over false colistin resistance results

    bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.

    Product
    VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export o
    Category
    Medical Device
    Distribution
    0 states
  • 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-0853-2023·2023-01-11

    VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure

    Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
    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-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-0818-2023·2023-01-11

    FDA Recalls Antibiotic Susceptibility Test Strips Due to Storage Condition Excursion

    Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2023·2023-01-11

    Medical Diagnostic Device Recalled Due to Temperature and Time Excursions

    Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.

    Product
    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2023·2023-01-11

    VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions

    Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.

    Product
    VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2023·2023-01-11

    FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.

    Product
    VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2023·2023-01-11

    ETEST Meropenem antibiotic susceptibility test recalled due to storage excursion

    Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.

    Product
    ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2023·2023-01-11

    PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect

    Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2023·2023-01-11

    Biomerieux PPM Culture Plates Recalled for Storage Stability Issues

    Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.

    Product
    PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    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-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-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2023·2023-01-11

    VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

    Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

    Product
    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
    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-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide