Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Recalled by Diagnostica Stago, Inc. Due to Potential for contamination of STA-LIQUID ANTI-Xa by Stago...

Date: July 21, 2025
Company: Diagnostica Stago, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.

Affected Products

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.

Quantity: 829,800 units (245,200 US)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Diagnostica Stago, Inc.

Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report