VITEK — Class II medical device recall Z-3134-2017
Terminated recall by Biomerieux Inc, reported 2017-09-27, distributed in GU. Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavu
| Recall number | Z-3134-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2017-08-25 |
| Classified | 2017-09-18 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2020-11-09 |
| Distributed | GU |
| Countries outside the US | AE, AR, AT, BE, CA, CH, CN, DE, EG, ES, FR, GB, GR, HR, HU, IL, IT, KR, LU, LV, MA, MX, NI, NL, OM, PA, PL, RS, SA, TN, TR, ZA |
| Quantity | 11,703 cartons |
| UPC / GTIN / UDI-DI | 03573026131920 |
| Lot numbers | 2420240403, 2420303403 |
| Model numbers | 21342 |
| Expiration dates | 2018-07-24, 2018-09-24 |
Product
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 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
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.
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-3134-2017. 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.