Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

On 11/5/2025, recall notices were mailed to Medical Directors, Lab Directors, Clinical Laboratory Managers, or Point of Care Coordinators who were asked to do the following: 1) Forward this communication to those within your organization who need to be aware and verify they understand the procedure and can complete the enclosed forms. 2) Forward the enclosed customer notification to all other organizations where affected devices may have been transferred. 3) Please check your inventory for affected devices. If you find any, please refrain from opening any pouches or using the product. Destroy all impacted cuvette pouches and/or boxes of the affected devices. 4) Complete and return the Customer Acknowledgment Form via email to ilsd_ra.na@werfen.com 5) If you have questions regarding replacement product, please contact the firm's Customer Service at 1-800-955-9525 or e-mail to customerservice.na@werfen.com. 6) For any technical related questions, please contact the firm's Technical Services at 1-800-678-0710 Option No. 1 or email to: techsupport.na@werfen.com

• FDA enforcement recordOfficial FDA database entry for Z-0880-2026
• FDA 510(k) clearance · K960749The device's official FDA premarket clearance record
• FDA device classification · JBPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7140The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Accriva Diagnostics, 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.