Xpert Gbs Assay (2017-12-08)

Xpert GBS Assay Recall Summary The Xpert GBS Assay, a medical device used to test for Group B Streptococcus (GBS), has been recalled across Canada. The specific reason for the recall relates to issues with the device itself, though the exact technical problem is not detailed in this notice. This recall affects all users of this product across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-02-01

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/54b359b4-a1c8-415f-af5c-3cf0f7a722de