BEUDAMED
    FDA Recall Terminated

    Software version 4.44A utilized on the BD MAX System

    Recall: Z-1864-2017 · Initiated July 29, 2015

    Recall

    Recall Number
    Z-1864-2017
    Event Number
    76900
    Firm
    BD LIFE SCIENCES
    FEI Number
    3013091131
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 29, 2015
    Posted
    April 4, 2017
    Terminated
    April 19, 2017
    Address
    54 Loveton Cir, Sparks Glencoe, MD, 21152-9202

    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.

    Action

    BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000.

    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.