Cobas Omni Lysis Reagent (2019-08-16)

COBAS OMNI LYSIS REAGENT Recall Summary Roche Diagnostics is recalling COBAS OMNI Lysis Reagent across Canada because the product may not work properly in certain laboratory testing situations. This is a Class I recall, meaning there is a serious risk to health. The affected reagent was distributed to hospitals and diagnostic laboratories nationwide.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-09-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bee88cba-c930-4859-bf89-a9c4c42f70c2