VITEK — Class II medical device recall Z-3180-2018
Terminated recall by bioMerieux, Inc., reported 2018-09-26, distributed nationwide. Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured wi
| Recall number | Z-3180-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-08-13 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, CZ, DE, NL, TR |
| Quantity | 10,919 cartons |
| Lot numbers | 8050348103, 8050452403, 8050655403, 8050690403 |
| Model numbers | 421913 |
Product
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: 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. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Reason for recall
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
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-3180-2018. 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.