BEUDAMED
    FDA Recall Terminated

    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    Recall: Z-1341-04 · Initiated June 10, 2004

    Recall

    Recall Number
    Z-1341-04
    Event Number
    29587
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2004
    Posted
    August 13, 2004
    Terminated
    November 19, 2004
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    Reason

    Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.

    Action

    The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.

    Distribution

    Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.

    Quantity

    171 units and 25 spare parts distributed