BEUDAMED
    FDA Enforcement Class II Ongoing

    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    Recall: Z-2323-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2323-2025
    Event ID
    97093
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Instrumentation Laboratory
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    February 3, 2025
    Classification Date
    August 13, 2025
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    Reason

    Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

    Code Info

    Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397;

    Distribution

    Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Macao, Malaysia, Mexico, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Vietnam.

    Quantity

    41,824 units