Public recall detail

HemosIL Heparin Calibrators

2025-01-02

medium
Recall Safety notice
Quick summary

Quick summary: HemosIL Heparin Calibrators. Date: 2025-01-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: HemosIL Heparin Calibrators. Date: 2025-01-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandINSTRUMENTATION LABORATORY CO.
ProductHemosIL Heparin Calibrators
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76788

Affected products

ProductHemosil Heparin Calibrators
LotMore than 10 numbers, contact manufacturer.
Model0020300600
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHemosil Heparin Calibrators
ProductHemosil LMW Heparin Controls
LotN1147397 N0632773 N0643673 N0441476 N0148986 N0935135 N1036592 N0330228 N0845161
Model0020300200
Serial numberN1147397 N0632773 N0643673 N0441476 N0148986 N0935135 N1036592 N0330228 N0845161
DescriptionHemosil LMW Heparin Controls

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76788
Background{}
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
AudiencesHealthcare
Source updated2025-01-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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