BEUDAMED
    FDA Recall Terminated

    ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038

    Recall: Z-0818-04 · Initiated March 19, 2004

    Recall

    Recall Number
    Z-0818-04
    Event Number
    28728
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 19, 2004
    Posted
    July 20, 2004
    Terminated
    November 3, 2005
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75015-2020

    Description

    ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038

    Reason

    When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.

    Action

    Customers were notified by letter on March 23, 2004 to contact their LIS vendor and to reconfigure the ASTM Field 10.1.4 to allow a maximum character length of 20 characters.

    Distribution

    Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore

    Quantity

    101