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Health Canada Medical devices

Beckman Coulter Au Immunochemistry System - Apolipoprotein B

Issued May 7, 2025
Issue
The Apo B lot 2631 VAS LOSR6143_2631_ML.01 contains an incorrect target value of 166 mg/dl for the level 4 calibrator ODR3022, lot 3000. The correct level 4 target value is 116 mg/dl. The value in g/l unit is correct. Recall Start Date: April 21, 2025
Hazard description
Labelling and packaging
Product
Product name
Beckman Coulter Au Immunochemistry System - Apolipoprotein B
Reference
ID
RA-77411