Ethanol Gen.2 (etoh2) For Cobas Integra And Cobas C Systems

Recall Summary Ethanol Gen.2 (EtOH2) reagent used in Cobas Integra and Cobas C laboratory analyzer systems is being recalled across Canada because it does not meet required purity specifications. This reagent is used in medical laboratories to perform diagnostic tests. The recall affects healthcare facilities and diagnostic laboratories in Canada that use these analyzer systems.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-04-04

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5dc714d9-feb9-4cad-b197-8a7cbb884972