Biomerieux Inc recalls BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceab
Recalled Product
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Hazard / Issue
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.
Issued by
FDA
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