BEUDAMED
    FDA Recall Terminated

    ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.

    Recall: Z-0416-2007 · Initiated December 12, 2006

    Recall

    Recall Number
    Z-0416-2007
    Event Number
    36996
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 12, 2006
    Posted
    February 7, 2007
    Terminated
    September 24, 2007
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.

    Reason

    The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.

    Action

    Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.

    Distribution

    Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.

    Quantity

    648 units.