Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;

Recall date

September 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0205-2026

FDA classification

Class II

Brand / firm

Diagnostica Stago, Inc.

Sold / distributed

Worldwide distribution- US Nationwide and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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