Class II

Medical Device Recall: Product: STA Liatest D-Di; REF: 00515;

Diagnostica Stago, Inc. · September 12, 2025

Reason for Recall

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

Distribution

Worldwide distribution- US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

12740 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0205-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Diagnostica Stago, Inc. Medical Device Recall: Product: STA Liatest D-Di; REF: 00515; | SafeCheck