VITEK 2 Compact — Class II medical device recall Z-1308-2021
Terminated recall by Biomerieux Inc, reported 2021-03-31, distributed in GU. bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result asso
| Recall number | Z-1308-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2021-01-28 |
| Classified | 2021-03-25 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2023-01-12 |
| Distributed | GU |
| Countries outside the US | AT, BD, BM, BR, CH, GR, HK, HU, ID, IE, IN, LK, LU, MX, MY, NG, NZ, PH, SE, SK, SV, TH, TN, UY |
| Quantity | 6,777 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03573026136789, 03573026136796, 03573026147495, 03573026147501, 03573026220624, 03573026220631 |
| Model numbers | C57 |
Product
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). 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
bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
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-1308-2021. 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.