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Health Canada Medical devices

Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)

Issued July 9, 2025
Issue
UIBC OSR61205 is not meeting interference claims for haemoglobin interference serum application. As per product ifus the claim is less than 10% up to 2g/l haemoglobin. While the high pool is meeting the claim, the low pool is failing the hemolysate interference specifications with results of -43.63% or -8.95 μmol/l. Recall start date: July 1, 2025
Hazard description
Performance
Product
Product name
Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
Reference
ID
RA-77710