Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2476-2025 — 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 Clauss.

U.S. FDA — Device Enforcement · United States · 2025-07-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2476-2025
Date of alert: 2025-07-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Diagnostica Stago, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 13607450006749

Reported risk: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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