BIOMERIEUX VIDAS 3 — Class II medical device recall Z-0928-2020
Terminated recall by Biomerieux Inc, reported 2020-02-12. Following Customers complaints, investigations have been initiated on potentially false results obtained on VI
| Recall number | Z-0928-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2020-01-31 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2024-08-06 |
| Quantity | 738 units |
| Reason classes | software |
Product
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Reason for recall
Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
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-0928-2020. 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.