The Recall Desk

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.

76–100 of 100

  • 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-0826-2023·2023-01-11

    Levofloxacin ETEST Clinical Test Recalled for Improper Storage Conditions

    Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of product performance.

    Product
    ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2023·2023-01-11

    Laboratory Testing Product Recall Due to Temperature Storage Excursion

    Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2023·2023-01-11

    Biomerieux CHROMID CARBA Laboratory Product Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee product performance.

    Product
    PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
    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-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-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-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-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-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-0844-2023·2023-01-11

    Laboratory Culture Medium Recalled Due to Storage Condition Failure

    Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.

    Product
    PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
    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-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-0852-2023·2023-01-11

    Medical Device Recall: ETEST Meropenem/Vaborbactam Due to Storage Temperature Excursion

    Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.

    Product
    ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2023·2023-01-11

    PPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion

    Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.

    Product
    PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
    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-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-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-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-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
  • 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
  • HighFDA (Devices)·Z-0525-2022·2022-02-02

    API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect

    Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.

    Product
    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either autom
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2021·2021-08-18

    In Vitro Diagnostic Test Produces Incorrect Antibiotic Susceptibility Results

    Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.

    Product
    ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide