bioMerieux VITEK 2 AST-N351 Test Kit Recall: False Positive ESBL Phenotype Risk
bioMerieux recalls VITEK 2 AST-N35:1 Test Kit (all lots) due to potential false positive ESBL phenotype results. This may lead to incorrect antibiotic treatment decisions. No specific remedy is stated in the recall notice.
Lower-risk recall
False Positive ESBL Phenotype
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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. Read more at govinfonow.com/recall/69342-biomerieux-vitek-2-ast-n351-test-kit-recall-false-positive.
Source Summary by GovInfoNow · govinfonow.com/recall/69342-biomerieux-vitek-2-ast-n351-test-kit-recall-false-positive · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0847-2019
Cite this page
“bioMerieux VITEK 2 AST-N351 Test Kit Recall: False Positive ESBL Phenotype Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69342-biomerieux-vitek-2-ast-n351-test-kit-recall-false-positive. Based on FDA recall #Z-0847-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2019%22&limit=1).
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
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.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.7 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.
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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.