Elecsys® Anti-tshr

Roche is recalling Elecsys® Anti-TSHR, a diagnostic test used to detect antibodies related to thyroid disease, across Canada due to performance issues with the product. The recall affects all users of this test in Canada. This is a Class I recall, meaning the product could cause serious adverse health effects.

Product
Elecsys® Anti-TSHR
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-12-23
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6dbb3b2a-23b5-4aeb-a0f3-7a2e5728c891