Lb2 (albumin Gen.2) For Cobas C701 Analyzer (2019-09-11)

Recall Summary Roche is recalling ALB2 (Albumin Gen.2) reagent for use with Cobas C701 laboratory analyzers across Canada due to a device issue. This product is used in medical laboratories to measure albumin levels in patient blood samples. The recall affects all units of this reagent distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-11-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3e63bcc2-1e8a-4ce7-a484-c092550fad7b