BEUDAMED
    FDA Enforcement Class II Terminated

    Software version 4.44A utilized on the BD MAX System

    Recall: Z-1864-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1864-2017
    Event ID
    76900
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD LIFE SCIENCES
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 26, 2017
    Initiation Date
    July 29, 2015
    Classification Date
    April 19, 2017
    Termination Date
    April 19, 2017
    Address
    54 Loveton Cir, N/A, Sparks Glencoe, MD, 21152-9202, United States

    Description

    Software version 4.44A utilized on the BD MAX System

    Reason

    The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the users display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. BD is able to trace the issue to a limited number of instruments that have software version 4.44A installed. Note that the problem only affects customers that are either creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.

    Code Info

    Catalog number 441916

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.

    Quantity

    There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A.