Reported Jul 15, 2026 · Ongoing
VITEK 2 AST-N447 TEST KIT Product reference 424620
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Lot codes and dates
- Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Amount recalled
- 45,900 cards
Why it was recalled
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
This product could cause temporary or reversible health problems — stop using it.
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