Class II — Potential Health Hazard

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

Product: STA Liatest D-Di Recalled by Diagnostica Stago, Inc. Due to A potential risk of underestimation of D-Dimer (D-Di)...

Date: September 12, 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

Product: STA Liatest D-Di; REF: 00515;

Quantity: 12740 units

Why Was This Recalled?

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

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