Kit Cobas 6800/8800 Hcv 96t Ce-ivd (2018-11-19)

Recall Summary The COBAS 6800/8800 HCV 96T test kit, used to detect hepatitis C virus, is being recalled across Canada due to issues with the medical device. This is a Class I recall, which indicates a serious problem with the product. The recall affects the test kits distributed throughout Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-12-10
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d8156751-56cb-4b4c-8f45-13af4435c404