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Beckman Coulter Au Immunochemistry System - Apolipoprotein B — recall 77411

Health Canada — Medical Devices · Canada · 2025-05-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77411
Date of alert
2025-05-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemi

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