Beckman Coulter Au Immunochemistry System - Bicarbonate (co2) Assay

Summary Beckman Coulter is recalling its Au Immunochemistry System Bicarbonate (CO2) Assay across Canada due to a performance issue with the test. This assay is used in laboratory settings to measure bicarbonate levels in patient blood samples. The recall affects all units of this product distributed in Canada.

Product
Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-04-13
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/20558ac0-ac12-4ad1-90f6-277cf353d950