Recall MonitorHealth Products
HemosIL Heparin Calibrators
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: HemosIL Heparin Calibrators
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Hemosil Heparin Calibrators | More than 10 numbers, contact manufacturer. | 0020300600 |
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