Aptima® Cmv Quant Assay

Aptima® CMV Quant Assay Recall Summary The Aptima® CMV Quant Assay, a test used to detect and measure cytomegalovirus (CMV) in patient samples, is being recalled across Canada due to performance issues. This is a Class I recall, meaning there is a potential serious adverse health consequence. The recall affects this medical test product distributed throughout Canada.

Product
Aptima® CMV Quant Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-12-06
Status
Closed
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c2e4475b-ff0f-4b89-9461-9d9b97ae3368