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Sta – liquid anti-xa

Official notice

31 Jul 2025

Last checked

31 Jul 2025

Critical riskHealth Canada

An official Health Canada notice concerns Sta – liquid anti-xa. Following internal tests, contamination of STA®-LIQUID ANTI-Xa by Stago Fibrinogen reagents was identified in UFH and LMWH applications on STA SATELLITE® or STA SATELLITE MAX® analyzers. Contamination occurs when one or more tests with the STA®-Fibrinogen 5 reagent are performed before the STA®-LIQUID ANTI-Xa test for heparin monitoring on an STA SATELLITE® or STA SATELLITE MAX® analyzer. This contamination causes an underestimation of heparin levels which could lead to a heparin treatment change and a subsequent overdose risk for the patient. Recall start date: July 21, 2025 Published 2025-07-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77769

Official notice

2025-07-31

The hazard

Following internal tests, contamination of STA®-LIQUID ANTI-Xa by Stago Fibrinogen reagents was identified in UFH and LMWH applications on STA SATELLITE® or STA SATELLITE MAX® analyzers. Contamination occurs when one or more tests with the STA®-Fibrinogen 5 reagent are performed before the STA®-LIQUID ANTI-Xa test for heparin monitoring on an STA SATELLITE® or STA SATELLITE MAX® analyzer. This contamination causes an underestimation of heparin levels which could lead to a heparin treatment change and a subsequent overdose risk for the patient. Recall start date: July 21, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77769

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Affected products

Product 1

Affected products - STA - Liquid Anti-Xa 4, Lot or serial number - All lots., Model or catalogue number - 00311US

Product 2

Affected products - STA - Liquid Anti-Xa 8, Lot or serial number - All lots., Model or catalogue number - 00322US

Product 3

Affected products - STA Satellite, Lot or serial number - All lots., Model or catalogue number - 58104

Product 4

Affected products - STA - Fib 2, Sta - Fibrinogen 5, Lot or serial number - All lots., Model or catalogue number - 00674

Product 5

Affected products - STA Satellite Max, Lot or serial number - All lots., Model or catalogue number - 59004

Risk / hazard

Following internal tests, contamination of STA®-LIQUID ANTI-Xa by Stago Fibrinogen reagents was identified in UFH and LMWH applications on STA SATELLITE® or STA SATELLITE MAX® analyzers. Contamination occurs when one or more tests with the STA®-Fibrinogen 5 reagent are performed before the STA®-LIQUID ANTI-Xa test for heparin monitoring on an STA SATELLITE® or STA SATELLITE MAX® analyzer. This contamination causes an underestimation of heparin levels which could lead to a heparin treatment change and a subsequent overdose risk for the patient. Recall start date: July 21, 2025

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Diagnostica Stago Sas, Sta – Liquid Anti-xa.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

77769

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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