Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its VIDAS CMV IgM [Ref.: 30205; Lots: 1008182270, 1008143230; 1008363970; 1008433580].

VIDAS CMV IgM is an automated qualitative enzyme immunoassay to be used on the VIDAS family instruments for the detection of anti-cytomegalovirus IgM (CMVM) in human serum, using Enzyme Linked Fluorescent Assay. The manufacturer received complaints of the following calibration issue observed on the affected products:

• In case of invalid calibration, an error message appears and it will not be possible to perform further testing.

To date, the manufacturer has identified that the standard S1 signal of the lot 1008182270 has a significant increase.

According to the manufacturer, in the case of invalid calibration, there is no risk of getting a false result, however there is a risk of delayed results if the analysis cannot be done. The manufacturer is advising the users to take the followings:

• Part I: required actions regarding lot 1008182270:
• As the issue has not been reproduced internally, the required action is based on the number of complaints recorded on each lot and on the monitoring of the signal evolution regarding the standard S1 of the calibration kits.
• Stop using and destroy any stock of lot 1008182270 of VIDAS CMV IgM (Ref. 30205).
• Part II: required actions regarding lots 1008143230; 1008363970; 1008433580:
• Users can continue to use the kits if the calibration is valid and they are advised to inform the manufacturer in case of invalid calibration.

The manufacturer is also advising users to follow "Good practices reminder" regarding the workflow to apply on VIDAS instruments.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary action.

Posted on 1 March 2021