BEUDAMED
    FDA Recall Open, Classified

    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

    Recall: Z-0880-2026 · Initiated November 5, 2025

    Recall

    Recall Number
    Z-0880-2026
    Event Number
    97942
    Firm
    Accriva Diagnostics, Inc.
    FEI Number
    2250033
    Product Code
    JBP
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    November 5, 2025
    Posted
    December 3, 2025
    Address
    6260 Sequence Dr, San Diego, CA, 92121-4358

    Description

    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

    Reason

    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.

    Action

    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 [email protected] 5) If you have questions regarding replacement product, please contact the firm's Customer Service at 1-800-955-9525 or e-mail to [email protected]. 6) For any technical related questions, please contact the firm's Technical Services at 1-800-678-0710 Option No. 1 or email to: [email protected]

    Distribution

    Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.

    Quantity

    20250