FDA Device recall Z-0928-2020
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation by Biomerieux, citing following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0928-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-22 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Reason
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.
Identifiers
| code_info | software versions 1.2 and higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2020%22
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