Biomerieux recalls VITEK 2 AST-N447 test kits with pouch foil fractures that may cause false resistance results for carbapenem and cephalosporin tests. This is a US-only product not registered in the US.
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Biomerieux is recalling VITEK 2 AST-N447 test kits that may give false results for certain antibiotics. This could lead to incorrect treatment decisions if used without fixing the issue.
Pouch foil fractures in the test kits can cause false results for carbapenem and cephalosporin resistance. This might lead to incorrect treatment choices if the test is used without addressing the issue.
Healthcare professionals using the VITEK 2 AST-N447 test kits with specific lot numbers. Those who rely on accurate antibiotic resistance testing are most at risk.
Check for lot number 0853293604 on the VITEK 2 AST-N447 test kit. The product is not registered in the US and is only sold outside the US.
Look for lot number 0853293604 on the VITEK 2 AST-N447 test kit packaging.
No, this product is not registered in the US and is only sold outside the US.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
The recall record does not mention any injury risk, so this is a low-risk issue.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2715-2026 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-2715-2026 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.
