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

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

On September 12, 2025 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were emailed to customers. Actions for customers: Discontinue use of affected lots and dispose of them in accordance with your local regulations. Complete and return response form. For additional information, please contact Stago's 24/7 Hotline at 1-800-725-0607.

• FDA enforcement recordOfficial FDA database entry for Z-0205-2026
• FDA 510(k) clearance · K141144The device's official FDA premarket clearance record
• FDA 510(k) clearance · K162227The device's official FDA premarket clearance record
• FDA 510(k) clearance · K964728The device's official FDA premarket clearance record
• FDA device classification · DAPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7320The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Diagnostica Stago, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.