Biomerieux VITEK 2 AST-N447 Kit Recall: False Resistance Results Risk
Biomerieux recalls VITEK 2 AST-N447 test kits with pouch foil fractures that may cause false resistance results for carbapenem and cephalosporin tests. This is a US-only product not registered in the US.
Lower-risk recall
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Contact the company
What happened, in plain English
Biomerieux is recalling VITEK 2 AST-N447 test kits that may give false results for certain antibiotics. This could lead to incorrect treatment decisions if used without fixing the issue. Read more at govinfonow.com/recall/49043-biomerieux-vitek-2-ast-n447-kit-recall-false-resistance-results.
Source Summary by GovInfoNow · govinfonow.com/recall/49043-biomerieux-vitek-2-ast-n447-kit-recall-false-resistance-results · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2715-2026
Cite this page
“Biomerieux VITEK 2 AST-N447 Kit Recall: False Resistance Results Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49043-biomerieux-vitek-2-ast-n447-kit-recall-false-resistance-results. Based on FDA recall #Z-2715-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2715-2026%22&limit=1).
Why it’s dangerous
Pouch foil fractures in the test kits can cause false results for carbapenem and cephalosporin resistance. This might lead to incorrect treatment choices if the test is used without addressing the issue.
Who’s affected
Healthcare professionals using the VITEK 2 AST-N447 test kits with specific lot numbers. Those who rely on accurate antibiotic resistance testing are most at risk.
How to tell if you have this one
Check for lot number 0853293604 on the VITEK 2 AST-N447 test kit. The product is not registered in the US and is only sold outside the US.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot number 0853293604 on the VITEK 2 AST-N447 test kit packaging.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-2715-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2715-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.