BEUDAMED
    FDA Recall Terminated

    Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

    Recall: Z-1148-03 · Initiated June 18, 2003

    Recall

    Recall Number
    Z-1148-03
    Event Number
    26726
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    KLS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2003
    Posted
    August 21, 2003
    Terminated
    April 20, 2004
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29

    Reason

    Defective software media distributed with upgrade software may cause installation failure and systems lock.

    Action

    Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.

    Distribution

    United States only, nationwide.

    Quantity

    1615