Biomerieux recalls specific VITEK 2 AST test kits (AST-N334, AST-GN95, etc.) due to potential false susceptible results for certain bacteria. Affected kits may mislead antibiotic treatment decisions.
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Biomerieux is recalling specific VITEK 2 AST test kits that could produce false susceptible results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions. This recall affects laboratory test kits used to determine antimicrobial susceptibility.
The test kits may show bacteria as susceptible to antibiotics when they are actually resistant, leading to incorrect treatment decisions. This risk occurs only for specific bacteria with minimum inhibitory concentrations (MICs) of 0.5, 1, or 2.
Laboratories using the recalled VITEK 2 AST test kits for antimicrobial susceptibility testing are affected. The risk is highest for labs that test bacteria with MIC values of 0.5, 1, or 2.
Check if your VITEK 2 AST test kit has the model numbers listed (AST-N334, AST-GN95, AST-GN99, etc.) and the specific lot/serial numbers provided in the recall notice.
Review the model number and lot/serial numbers on your VITEK 2 AST test kit to determine if it is affected by this recall.
The affected kits include AST-N334 (REF 418984), AST-GN95 (REF 421982), AST-GN99 (REF 423102), and other specific models with the lot/serial numbers listed in the recall notice.
The kits may show bacteria as susceptible to antibiotics when they are actually resistant, potentially leading to incorrect antibiotic treatment decisions for bacteria with MIC values of 0.5, 1, or 2.
No, but you should check if your kit is affected by reviewing the model numbers and lot/serial numbers provided in the recall notice.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1464-2024 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1464-2024 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.
