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Health Canada Medical devices

Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)

Issued August 3, 2023
Issue
Internal testing determined that IgA OSR61171 failed to meet the interference claim as stated per the IFU for the lipemic serum interference. All lots of IgA OSR61171 are affected. Recall start date: July 17, 2023
Hazard description
Performance
Product
Product name
Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)
Reference
ID
RA-74059