Biomerieux Inc. has recalled over 2.6 million VITEK 2 Gram-negative Susceptibility Cards because they may produce incorrect quality control results or show false antibiotic resistance when testing certain bacteria like Enterobacterales and Pseudomonas aeruginosa. This recall affects a wide range of product models distributed worldwide and nationwide in the U.S. Laboratory professionals use these cards to determine which antibiotics will effectively treat a patient's infection.
If the test cards provide false resistance results, a patient might be denied an effective antibiotic treatment, or their treatment could be delayed while clinicians investigate the inconsistent results. This defect can also lead to laboratory quality control failures.
Product references include Card Names: AST-N399, AST-N402, AST-N403, AST-N404, AST-N405, AST-N406, AST-N407, AST-N409, AST-N412, AST-N413, AST-N414, AST-N415, AST-N416, AST-N417, AST-N419, AST-N421, AST-N428, AST-N429, AST-N430, AST-N433, AST-N439, AST-N440, AST-N443, AST-N444, AST-N467, AST-N476, AST-N478, AST-N480, AST-N481, AST-N485, AST-N496, AST-N800, AST-N802, AST-N804, AST-N808, AST-N810, AST-N811, AST-N813, AST-N815, AST-XN09, AST-XN15, AST-XN17, AST-XN18, AST-XN20, AST-XN21, AST-XN22, AST-XN23, AST-XN24, AST-XN26, AST-XN28, AST-XN29, AST-XN30, AST-XN31, AST-XN32, AST-XN33, AST-XN34, AST-XN35, AST-XN36, AST-XN37, AST-XN38, AST-XN39, AST-XN40, AST-XN41, AST-XN42, AST-N484, AST-N486, AST-N491, AST-N494, AST-N504.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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