VITEK 2 / MYLA VITEK 2 Software versions 8 — Class II medical device recall Z-1640-2022
Ongoing recall by bioMerieux, Inc., reported 2022-09-07. There are 7 reported software anomalies that may affect use of the device.
| Recall number | Z-1640-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2022-07-13 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Countries outside the US | BH, EE, GB, PK, SA, SG, TH, VN |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03573026553968, 03573026609399, 03573026613914, 03573026619060, 03573026619244, 03573026621568 |
Product
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Reason for recall
There are 7 reported software anomalies that may affect use of the device.
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-1640-2022. 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.