Public recall detail

STA – Liquid Anti-Xa

2025-07-25

medium
Recall Safety notice
Quick summary

Quick summary: STA – Liquid Anti-Xa. Date: 2025-07-25.

Recommended action

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

Recall details

Quick summary: STA – Liquid Anti-Xa. Date: 2025-07-25.

Official details

Affected product details

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

BrandDiagnostica Stago Sas
ProductSTA – Liquid Anti-Xa
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77769

Affected products

ProductSTA - Liquid Anti-Xa 4
LotAll lots.
Model00311US
Serial numberAll lots.
DescriptionSTA - Liquid Anti-Xa 4
ProductSTA - Liquid Anti-Xa 8
LotAll lots.
Model00322US
Serial numberAll lots.
DescriptionSTA - Liquid Anti-Xa 8
ProductSTA Satellite
LotAll lots.
Model58104
Serial numberAll lots.
DescriptionSTA Satellite
ProductSTA - Fib 2, Sta - Fibrinogen 5
LotAll lots.
Model00674
Serial numberAll lots.
DescriptionSTA - Fib 2, Sta - Fibrinogen 5
ProductSTA Satellite Max
LotAll lots.
Model59004
Serial numberAll lots.
DescriptionSTA Satellite Max

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesDiagnostica Stago Sas 3 Allee Theresa, Asnieres Sur Seine, France, 92600
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77769
Background{}
CompaniesDiagnostica Stago Sas 3 Allee Theresa, Asnieres Sur Seine, France, 92600
AudiencesHealthcare
Source updated2025-07-31

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

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