Instrumentation Laboratory recalls The product is used for the evaluation of the intrinsic coagulation pathway

Potential for microbial contamination.

Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided.

• FDA enforcement recordOfficial FDA database entry for Z-1095-2026
• FDA 510(k) clearance · K060688The device's official FDA premarket clearance record
• FDA device classification · GFOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7925The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Instrumentation LaboratorySearch 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.