bioMerieux recalls VITEK 2 Gram Positive Cefoxitin and Oxacillin test kits due to increased non-detected MRSA cases. Affected kits have specific UDI numbers and are used in lab testing.
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
bioMerieux is recalling certain VITEK 2 Gram Positive test kits because lab reports show more MRSA bacteria going undetected. This matters because MRSA is a dangerous infection that can cause serious health issues if not treated properly.
The test kits may fail to detect MRSA (a type of bacteria that causes serious infections) in lab samples. This happens because the test has a higher rate of false negatives, meaning it might show bacteria as not present when they actually are.
Lab users who have the VITEK 2 Gram Positive Cefoxitin Screen or Oxacillin test kits with specific UDI numbers are affected. Healthcare professionals using these kits for bacterial testing are most at risk.
Check for UDI numbers starting with 03573026426804, 03573026242060, 03573026355173, 03573026437183, or 03573026553982 on the test kits. These are specific to the VITEK 2 AST-P631, AST-GP67, AST-GP71, AST-GP75, and AST-GP78 kits.
Look for specific UDI numbers on the test kits to confirm if they are affected.
Customer reports showed an increase in MRSA going undetected with these test kits.
Check the UDI numbers on the kits to see if they are affected. If they are, contact bioMerieux for guidance.
The recall is for lab use only; there are no direct safety risks to end users.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2817-2018 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-2817-2018 from bioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
