Recall archive / FDA device enforcement
VITEK 2 AST-N447 TEST KIT Product reference 424620 — FDA record Z-2715-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Reason
- Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
- Classification
- Class II
- Recalling firm
- Biomerieux Inc
- Quantity
- 45,900 cards
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2715-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Belgium and the Netherlands.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 15, 2026
- Recall initiation date
- Jun 4, 2026
- Center classification date
- Jul 9, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.