Xpert Ev Assay

The Xpert EV Assay, a diagnostic test, is being recalled across Canada due to performance issues. This Class I recall means the product may not work as intended. The recall affects this drug product distributed throughout Canada.

Product
Xpert EV Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-09-20
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cbbb8fa9-cb35-488b-80cf-d6ab0d5aaabe