FDAFDA recall Z-2715-2026 · Jul 15, 2026
Biomerieux Inc: VITEK 2 AST-N447 TEST KIT Product reference 424620 recall
Recall found
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Reason for recall
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Quantity
- 45,900 cards
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
- Recalling firm
- Biomerieux Inc, Hazelwood, MO
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-04
Source: openFDA enforcement record Z-2715-2026 · search recall number Z-2715-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.