VITEK MS CLINICAL REAGENT VITEK MS-CHCA — Class II medical device recall Z-0815-2023
Ongoing recall by Biomerieux Inc, reported 2023-01-11, distributed nationwide. As the temperature and time out of range was exceeded, product performances cannot be guaranteed
| Recall number | Z-0815-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2022-11-09 |
| Classified | 2023-01-04 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 46 units |
| UPC / GTIN / UDI-DI | 03573026362836 |
| Lot numbers | 1009391190, 1009434380, 1009472100 |
| Model numbers | 411071 |
Product
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
Reason for recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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-0815-2023. 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.