Xpert® Xpress Strep A

Xpert® Xpress Strep A Recall Summary Xpert® Xpress Strep A, a rapid diagnostic test for strep A infection, is being recalled across Canada due to performance issues with the test. This is a Class I recall, which means the product could cause serious health problems or death. The recall affects all units of this product distributed in Canada.

Product

Xpert® Xpress Strep A

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2023-11-24

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/aef0d590-fa6f-43ae-8872-fb4b01c15383