Immage Immunochemistry System Igm Immunoglobulin M Reagent (2019-04-21)

Recall Summary Beckman Coulter is recalling IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent distributed across Canada because the reagent may produce inaccurate test results. This reagent is used in laboratory testing to measure IgM antibodies in patient blood samples. The recall affects healthcare facilities and laboratories that use this testing system.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-06-28
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2c4d1bd6-64c7-45b2-8616-bc1c3e9c1526