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Health Canada Medical devices

HemosIL Heparin Calibrators

Issued January 2, 2025
Issue
Instrumentation Laboratory has received complaints of heparin controls reporting low out of their assigned acceptance range with HemosIL Liquid Anti-XA, leading to delays in patient testing. Our internal investigation has identified that the value assignment of the HemosIL Heparin Calibrators has shown a bias against the who international standards for UFH and LMWH, potentially causing reduced recovery when measuring heparin on both controls and samples. Recall start date: December 18, 2024
Hazard description
Performance
Product
Product name
HemosIL Heparin Calibrators
Reference
ID
RA-76788