VIDAS FSH — Class II medical device recall Z-0434-2022
Ongoing recall by bioMerieux, Inc., reported 2022-01-05, distributed nationwide. bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevent
| Recall number | Z-0434-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2021-09-22 |
| Classified | 2021-12-28 |
| Reported by FDA | 2022-01-05 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 03573026156947 |
| Lot numbers | 1008781470 |
| Model numbers | 30407-01 |
Product
VIDAS FSH, REF 30407-01
Reason for recall
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
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-0434-2022. 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.