Health product recall

HemosIL Heparin Calibrators

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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