BEUDAMED
    FDA Recall Terminated

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    Recall: Z-1662-2013 · Initiated May 31, 2013

    Recall

    Recall Number
    Z-1662-2013
    Event Number
    65431
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    NJR
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 31, 2013
    Posted
    July 3, 2013
    Terminated
    August 19, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    Reason

    Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.

    Action

    Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.

    Distribution

    Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.

    Quantity

    71 instruments