VITEK 2 AST-N447 TEST KIT Product reference 424620 — Class II medical device recall Z-2715-2026
Ongoing recall by Biomerieux Inc, reported 2026-07-15. Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from af
| Recall number | Z-2715-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2026-06-04 |
| Classified | 2026-07-09 |
| Reported by FDA | 2026-07-15 |
| Countries outside the US | BE, NL |
| Quantity | 45,900 cards |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 03573026634551 |
| Lot numbers | 0853293604 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2715-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.