Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF…

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

On February 5, 2026 QUALITY ALERT letters were emailed to customers. Actions required: 1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents. 2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form. In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov website, for instructions. For additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.

• FDA enforcement recordOfficial FDA database entry for Z-1585-2026
• FDA 510(k) clearance · K162227The 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.