Home / Recalls / Medical Devices
Biomerieux Inc recalls BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Recalled February 12, 2020 · FDA recall Z-0928-2020 · Biomerieux
Hazard
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. · FDA Class II
Units
738 units
Sold at
US
Description
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.
Product
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →