BEUDAMED
    FDA Enforcement Class II Ongoing

    BD COR System Software. Model Number: 444829.

    Recall: Z-2162-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2162-2025
    Event ID
    97142
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 30, 2025
    Initiation Date
    June 23, 2025
    Classification Date
    July 23, 2025
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD COR System Software. Model Number: 444829.

    Reason

    Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

    Code Info

    Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.

    Distribution

    Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.

    Quantity

    7 systems