bioMerieux VITEK 2 AST-N351 Test Kit Recall: False Positive ESBL Phenotype Risk

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Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402

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✎ GovInfoNow plain-language explainer

What happened, in plain English

bioMerieux is recalling all lots of the VITEK 2 AST-N351 Test Kit because it can cause false positive results for ESBL phenotypes. This might lead to incorrect antibiotic treatment decisions, which could affect patient care.

Why it’s dangerous

The test kit may produce false positive results for ESBL (Extended-Spectrum Beta-Lactamase) phenotypes. This can lead to incorrect antibiotic treatment decisions, potentially causing ineffective therapy or adverse effects.

Who’s affected

Healthcare professionals using the VITEK 2 AST-N351 Test Kit for bacterial identification are most likely affected. Patients receiving antibiotics based on incorrect test results could be at risk.

How to tell if you have this one

Check if you own the VITEK 2 AST-N351 Test Kit with reference number 421257. All lots of this product are affected by the recall.

Brand
bioMerieux
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if your VITEK 2 AST-N351 Test Kit has reference number 421257 and is from all lots.

✎ GovInfoNow

Questions people ask

Is there a specific remedy for this recall?

The recall notice does not state any remedy or action required.

What is the risk of using this test kit?

The test kit may produce false positive results for ESBL phenotypes, which could lead to incorrect antibiotic treatment decisions.

How can I tell if I have the recalled product?

The recalled product is the VITEK 2 AST-N351 Test Kit with reference number 421257, and all lots are affected.

Take action

Contact bioMerieux

We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0847-2019 — bioMerieux bioMerieux

Hello,

I own a bioMerieux that is covered by recall Z-0847-2019 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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Where this comes from

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.

Official source: FDA Recall #Z-0847-2019 (December 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0847-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

bioMerieux, Inc. recalls VITEK 2 AST-N351 Test Kit

Lower-risk recall