VITEK¿ 2 Systems Software Version 9 — Class II medical device recall Z-0639-2019
Terminated recall by bioMerieux, Inc., reported 2018-12-26, distributed nationwide. The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information
| Recall number | Z-0639-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-11-13 |
| Classified | 2018-12-19 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-07-07 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03573026561260 |
Product
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Reason for recall
The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.
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-0639-2019. 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.