VIDAS 3 software v — Class II medical device recall Z-1200-2017
Terminated recall by BioMerieux SA, reported 2017-02-22. During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be
| Recall number | Z-1200-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2017-01-11 |
| Classified | 2017-02-14 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-08-28 |
| Quantity | 1,161 units |
| Reason classes | software |
| Model numbers | 412590 |
Product
VIDAS 3 software v. 1.1.4
Reason for recall
During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
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-1200-2017. 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.