Z-0928-2020 Class II Terminated
FDA device recall Z-0928-2020 was initiated by Biomerieux Inc on October 22, 2019 and is designated Class II. 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 … The recall status is terminated (terminated August 6, 2024). Affected quantity: 738 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- October 22, 2019
- Termination Date
- August 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 738 units
Product Description
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.
Distribution Pattern
US
Code Information
software versions 1.2 and higher