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.

126–150 of 422

  • HighFDA (Devices)·Z-1308-2021·2021-03-31

    Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect

    Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.

    Product
    VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent ca
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1793-2020·2020-04-29

    bioMerieux PREVI Isola Printer Power Supply Units Recalled for Fire Hazard

    bioMerieux is recalling PREVI Isola printer power supply units due to a potential fire hazard. The affected units are distributed worldwide.

    Product
    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2020·2020-04-29

    Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives

    Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.

    Product
    The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1534-2020·2020-04-01

    bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals

    bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.

    Product
    VITEK 2 card AST-N371 - Product Usage: The 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. The VITEK 2 utilizes growth-based biochemical patterns
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2020·2020-02-19

    bioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits

    bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.

    Product
    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2020·2020-02-12

    Biomerieux VIDAS 3 Immunoanalyzer Recalled for False Results Due to Software Error

    Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.

    Product
    BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1137-2019·2019-04-24

    bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results

    bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.

    Product
    Biomerieux Vitek 2 Test kit 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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0847-2019·2019-02-27

    bioMerieux Recalls VITEK 2 AST-N351 Test Kits Due to False Positives

    bioMerieux, Inc. is recalling VITEK 2 AST-N351 Test Kits distributed in the UK and Ireland because they may produce false positive results for ESBL phenotypes.

    Product
    VITEK 2 AST-N351 Test Kit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0618-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to False Results

    bioMerieux is recalling VITEK 2 Streptococcus Susceptibility Cards because they may produce false resistant results for specific Streptococcus strains.

    Product
    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0230-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 8 BACT/ALERT VIRTUO systems because firmware version R2.0 allows calibration standards to be moved, potentially causing anomalies if not returned to designated locations.

    Product
    BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3180-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P655 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P655 cards because six lots were manufactured with insufficient gentamicin, potentially affecting high-level resistance screening results.

    Product
    VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2018·2018-08-29

    bioMerieux VITEK 2 Gram Positive Test Kits Recalled for MRSA Detection Issues

    bioMerieux is recalling VITEK 2 Gram Positive Test Kits because customer reports indicated an increased rate of non-detected MRSA.

    Product
    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2018·2018-08-08

    bioMerieux Recalls VIDAS LH Test Kits Due to Calibration Issues

    bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.

    Product
    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Lin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2018·2018-07-18

    bioMerieux Recalls VIDAS Analyzers and Quality Control Tests for Performance Issues

    bioMerieux is recalling VIDAS analyzers and Quality Control VIDAS tests due to pump clogging and label displacement that may cause erroneous assay results.

    Product
    BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2018·2018-07-18

    bioMerieux Recalls mini VIDAS Systems Due to Performance Issues

    bioMerieux is recalling 1,866 mini VIDAS systems because pump clogging and label displacement may cause erroneous test results.

    Product
    BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3134-2017·2017-09-27

    BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures

    BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing testing failures.

    Product
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growt
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3119-2017·2017-09-20

    bioMerieux Recalls eMAG System Due to Manufacturing Anomalies

    bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.

    Product
    eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3076-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.

    Product
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states