Manufacturer
45 recalls in our database name BioMerieux SA as the manufacturing or recalling firm.
Of the 45 recalls from BioMerieux SA we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
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.
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
BioMerieux is recalling 42 units of NucliSENS Magnetic Extraction Reagents because data loggers indicated one shipment experienced low temperatures that may impact performance.
BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.
BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.
BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.
BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.
BioMerieux is recalling VITEK 2 ANC identification cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.
BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.
BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.
BioMerieux SA is recalling 911 units of NucliSENS Lysis Buffer because residual heme may inhibit PCR reactions, leading to uninterpretable test results.
BioMerieux SA is recalling Ceftriaxone ETEST kits due to a potential performance issue affecting strain categorization.
BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.
BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.
BioMerieux SA is recalling NucliSENS Lysis Buffer because colored eluates were observed during whole blood extractions.
BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.
BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.
BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.
BioMerieux SA is recalling ETEST Ceftriaxone antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.