Beckman Coulter Au Immunochemistry System- Immunoglobulin M (igm)

Recall Summary Beckman Coulter is recalling Au Immunochemistry System reagent kits used to test for Immunoglobulin M (IgM) in patient blood samples due to performance issues with the test results. The recall affects all units distributed across Canada. This is a Class I recall, meaning there is a serious potential for health problems.

Product
Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM)
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-06-07
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/573950b0-cc28-4dfb-8195-6d0028a62691