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.

76–100 of 422

  • ModerateFDA (Devices)·Z-0821-2023·2023-01-11

    ETEST Ceftriaxone Antibiotic Test Strips Recalled for Storage Condition

    Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.

    Product
    ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0806-2023·2023-01-11

    Biomerieux BIOBALL B.SPIZIZENII culture products recalled for storage failure

    Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.

    Product
    BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2023·2023-01-11

    Biomerieux Culture Media Recalled Due to Temperature and Time Excursions

    Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0863-2023·2023-01-11

    ETEST Clinical Colistin Test Product Recalled Due to Storage Conditions

    Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.

    Product
    ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2023·2023-01-11

    ETEST Clinical Imipenem Susceptibility Test Kits Recalled Due to Storage Deviation

    Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.

    Product
    ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2023·2023-01-11

    PPM Clinical CHROMID MRSA diagnostic product recalled due to storage condition exceedance

    Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.

    Product
    PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2023·2023-01-11

    VIDAS Quality Control Product Recalled for Storage Condition Deviation

    Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

    Product
    VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2023·2023-01-11

    VIDAS HCG 60 Clinical Test Kits Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.

    Product
    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0816-2023·2023-01-11

    Clinical Reagent Vitek MS-FA Recalled Due to Storage Condition Violations

    Biomerieux is recalling VITEK MS-FA clinical reagent due to storage condition violations that degrade product performance. The recall affects 29 units distributed nationwide.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2023·2023-01-11

    Microbiological susceptibility test strips recalled for temperature and time excursion

    Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.

    Product
    ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2023·2023-01-11

    Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions

    Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.

    Product
    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2023·2023-01-11

    PPM Lombard R2A Laboratory Medium Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.

    Product
    PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2023·2023-01-11

    Biomerieux Recalls VITEK 2 Diagnostic Test Kit Due to Storage Conditions

    Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.

    Product
    VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2023·2023-01-11

    Bioball Fungal Reference Standard Recalled for Temperature Storage Issues

    Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.

    Product
    BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GN79 Reagent Test Kit for Temperature Excursion

    Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product performance.

    Product
    VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0832-2023·2023-01-11

    Biomerieux Recalls BIOBALL K.RHIZOPHILA Diagnostic Kits Due to Storage Failure

    Biomerieux Inc recalls BIOBALL K.RHIZOPHILA diagnostic kits (batch 7408) due to exceeded temperature and time storage conditions that may compromise product performance.

    Product
    BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2023·2023-01-11

    Medical Device Reagent Recalled for Temperature Storage Condition Failure

    Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.

    Product
    GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0791-2023·2023-01-11

    VITEK 2 Reagent Test Kit Recalled Due to Storage Temperature and Time Exceedance

    Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. Product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0804-2023·2023-01-11

    C. difficile diagnostic kit recalled due to storage temperature deviation

    Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.

    Product
    PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2023·2023-01-11

    FDA Recalls ETEST Clinical Benzylpenicil Test Due to Storage Excursion

    Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.

    Product
    ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2023·2023-01-11

    Biomerieux BIOBALL P.AERUGINOSA Quality Control Product Recalled for Temperature Excursion

    Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.

    Product
    BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2023·2023-01-11

    Biomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance

    Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.

    Product
    VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0854-2023·2023-01-11

    Biomerieux VITEK 2 AST-GN99 Diagnostic Test Kit Recalled for Storage Stability

    Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise test performance.

    Product
    VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2023·2023-01-11

    API NIT1 NIT2 Reagents Recalled Due to Improper Storage Conditions

    Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.

    Product
    API NIT1 NIT2 REAGENTS, CATALOG 70442
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2022·2022-10-05

    VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations

    bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.

    Product
    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
    Category
    Medical Device
    Distribution
    18 states