Official recall record
HemosIL Heparin Calibrators
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.