The Recall Desk
HighFDA (Devices)·Z-2473-2025·Announced 2025-09-03

STA Satellite Analyzer Recalled for Potential Reagent Contamination

Diagnostica Stago recalls STA Satellite analyzers due to potential contamination of STA-LIQUID ANTI-Xa reagent by Stago Fibrinogen reagents in heparin applications. The contamination could affect the accuracy of coagulation test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA device recall involving potential contamination of critical coagulation reagents that could affect patient anticoagulation monitoring. Although no illnesses or injuries have been reported and the contamination is described as 'potential' rather than confirmed, the nature of the hazard—cross-contamination affecting test accuracy in hemostasis testing—meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The U.S. Food and Drug Administration has identified a potential contamination issue affecting the STA Satellite, a fully automated benchtop analyzer used in laboratory settings for blood coagulation, chromogenic, and immunologic testing. The device performs multiple assay types simultaneously, critical for clinical decision-making in patient care.

The recall concerns a potential for contamination of the STA-LIQUID ANTI-Xa reagent by Stago Fibrinogen reagents when used in unfractionated heparin (UFH) and low molecular weight heparin (LMWH) applications. Such contamination could affect the accuracy of anticoagulation monitoring tests.

Approximately 3,650 STA Satellite analyzers have been distributed worldwide, with 538 units located in the United States. The analyzers are used in clinical laboratories across multiple states and numerous countries.

The recalled product

Product
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
  • reagent-contamination
  • test-accuracy-impact

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code: All references. UDI-DI: 03607450581041
  • 03607450581027. All software versions.

Distribution

Distributed nationwide across the United States.

Related recalls

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