HemosIL Heparin Calibrators
Brand(s)
Last updated
Summary
Product
HemosIL Heparin Calibrators
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Hemosil Heparin Calibrators | More than 10 numbers, contact manufacturer. | 0020300600 |
| Hemosil LMW Heparin Controls | N1147397 N0632773 N0643673 N0441476 N0148986 N0935135 N1036592 N0330228 N0845161 | 0020300200 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Instrumentation Laboratory Co. |
| 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76788
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