Elecsys Anti-tshr (2018-08-21)

Recall Summary Elecsys Anti-TSHR is a medical device used in laboratory testing that was recalled across Canada. The device was recalled due to safety or performance concerns classified as serious enough to warrant a Class I recall, the most severe category. The recall affected all Canadian distribution of this product.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-01-11

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/543a3211-638f-4ecc-83e1-766cf07d2723