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Hemosil heparin calibrators

Official notice

2 Jan 2025

Last checked

2 Jan 2025

Medium riskHealth Canada
Watch Instrumentation Laboratory

An official Health Canada notice concerns Hemosil heparin calibrators. 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 Published 2025-01-02.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76788

Official notice

2025-01-02

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76788

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Affected products

Product 1

Affected products - Hemosil Heparin Calibrators, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 0020300600

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Instrumentation Laboratory, Hemosil Heparin Calibrators

Manufacturer

Not provided

Phone

Not provided

Brand: Instrumentation Laboratory, Hemosil Heparin Calibrators.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76788

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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