VITEK¿ 2 Gram-negative AST Test Kits — Class II medical device recall Z-2671-2025
Ongoing recall by bioMerieux, Inc., reported 2025-10-08. Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa an
| Recall number | Z-2671-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2025-06-26 |
| Classified | 2025-09-29 |
| Reported by FDA | 2025-10-08 |
| Countries outside the US | AT, AU, BE, BG, CH, CN, CY, CZ, DE, ES, FR, GR, HR, IL, IN, IT, JP, KR, LT, MY, NL, PK, PL, PT, RO, RS, RU, SK, TH, TR, TW |
| Quantity | 235,269 cards |
| Pathogens | pseudomonas |
| Lot numbers | 423936, 424840, 424842, 424891, AST-N412, AST-N463, AST-N465, AST-N475 |
Product
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
Reason for recall
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
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-2671-2025. 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.