Biomerieux Vitek 2 Test Kit Recall: ESBL Risk in Bacterial Testing
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/68672-biomerieux-vitek-2-test-kit-recall-esbl-risk-in-bacterial.
Source Summary by GovInfoNow · govinfonow.com/recall/68672-biomerieux-vitek-2-test-kit-recall-esbl-risk-in-bacterial · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1137-2019
Cite this page
“Biomerieux Vitek 2 Test Kit Recall: ESBL Risk in Bacterial Testing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68672-biomerieux-vitek-2-test-kit-recall-esbl-risk-in-bacterial. Based on FDA recall #Z-1137-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1137-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Kit Identifiers
Look for the unique device identifiers listed: 03573026404550 (AST-N254), 03573026474836 (AST-N330), or 03573026604363 (AST-N371).
How this recall unfolded
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these kits immediately?
The recall does not require immediate stop use; labs should check identifiers and follow the provided steps.
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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-1137-2019 (March 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1137-2019 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.