Biomerieux recalls specific Vitek 2 test kits for potential ESBL bacteria misidentification risk in lab testing. Affected kits include AST-N254, AST-N330, and AST-N371 models with unique identifiers.
Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.
Biomerieux is recalling certain Vitek 2 test kits that could misidentify bacteria with ESBL traits. This risk affects lab testing accuracy, potentially leading to incorrect treatment decisions.
The test kits may misidentify bacteria with ESBL traits, which can lead to incorrect antibiotic treatment decisions. This happens because the test kits have been linked to unexpected ESBL phenotypes in some E. coli strains.
Laboratories using the specific Vitek 2 test kits with AST-N254, AST-N330, or AST-N371 models are most affected. The risk is for lab technicians and healthcare providers handling bacterial samples.
Check for the unique device identifiers: 03573026404550 (AST-N254), 03573026474836 (AST-N330), or 03573026604363 (AST-N371). The kits were sold with specific reference numbers 413723, 418674, and 422024.
Look for the unique device identifiers listed: 03573026404550 (AST-N254), 03573026474836 (AST-N330), or 03573026604363 (AST-N371).
The test kits may misidentify bacteria with ESBL traits, which can lead to incorrect antibiotic treatment decisions in lab testing.
The affected kits are AST-N254, AST-N330, and AST-N371 models with unique device identifiers 03573026404550, 03573026474836, and 03573026604363 respectively.
The recall does not require immediate stop use; labs should check identifiers and follow the provided steps.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1137-2019 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1137-2019 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.
