Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its VIDAS 3 System [Software version: 1.1.0, 1.1.1, 1.1.2; Part Number.: 412590; Serial Number.: All].
The manufacturer has identified three (3) anomalies with the VIDAS 3 System Software Version 1.1.0, 1.1.1 and 1.1.2.
The first anomaly occurs if the user launches a new calibration for a lot of a VIDAS test, for which an expired calibration already exists, and an instrument error happens during analytical phase (protocol) of the control. Under these specific conditions, the software calculates the sample results without flagging them with the message "incomplete calibration". However, the overall calibration status is flagged as "incomplete" in the calibration screen.
The second anomaly concerns the management of the analysis request of the test VIDAS CMV Avidity (CMVU) ref. 30203 and VIDAS CMV Avidity II (CMVA) ref. 413557.
The third anomaly concerns the stability of urea buffer used for the test VIDAS CMVU ref. 30203and VIDAS CMVA ref. 413557 when it is dispensed in the strip.
The potential risk associated with the first anomaly is to have a false result. It could concern all VIDAS 3 reagent parameters. The potential risk associated with the second and third anomalies is to have a false negative result for the test CMV IgG ref. 30204 and a false high result for the tests VIDAS CMVU ref. 30203 and VIDAS CMVA ref. 413557.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 October 2014