The Recall Desk
HighFDA (Devices)·Z-2476-2025·Announced 2025-09-03

Fibrinogen diagnostic kit contamination risk in heparin applications

Diagnostica Stago is recalling STA-Fibrinogen 5 diagnostic kits due to potential contamination that could affect anticoagulation monitoring tests in patients receiving heparin therapy.

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 FDA Class II recall involves potential contamination of diagnostic reagents used in clinical anticoagulation monitoring. The source describes the hazard as potential (theoretical risk) and does not report any illnesses, injuries, or deaths. Per the rubric, theoretical hazards with no reported injuries score at most 3. This constitutes a risk-of-harm product where clinical consequences could occur but have not yet been reported, meeting criteria for High (Score 3).

Plain-English summary

Diagnostica Stago, Inc. is recalling STA-Fibrinogen 5 diagnostic reagent kits (Model 00674) due to potential contamination risk. The Fibrinogen reagent from this kit could contaminate the STA-LIQUID ANTI-Xa reagent, which is used in laboratory testing to monitor anticoagulant levels in patients receiving heparin therapy.

Contamination of the STA-LIQUID ANTI-Xa reagent could result in inaccurate laboratory test results for anticoagulation monitoring, potentially affecting clinical decision-making for patients on heparin-based anticoagulation therapy.

The STA-Fibrinogen 5 kit is used with STA-R, STA Compact, and STA Satellite analyzer families. In the United States, 245,200 units have been distributed across 23 states and Puerto Rico. Worldwide, 829,800 units have been distributed.

Healthcare facilities should contact Diagnostica Stago for specific information regarding affected product lots and instructions for managing or returning potentially contaminated inventory.

The recalled product

Product
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
  • contamination

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 (1)

  • Model/Catalog Number: 00674. UDI-DI: 13607450006749

Distribution

Distributed nationwide across the United States.

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