BEUDAMED
    FDA Recall Terminated

    SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma.

    Recall: Z-1432-2012 · Initiated March 26, 2009

    Recall

    Recall Number
    Z-1432-2012
    Event Number
    53049
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JIF
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 26, 2009
    Posted
    April 16, 2012
    Terminated
    April 18, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma.

    Reason

    The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.

    Action

    Beckman Coulter mailed a Product Corrective Action (PCA) Letter on April 13, 2009 dated April 10, 2009 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue use and discard appropriately the lot number(s) of the affected product and contact their Customer Service Representative at (800) 526-3821 (US), or (800)463-7828 for reagent replacement. Customers were instructed to complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain records. Customers were told to call the Customer Support Center (Hotline) at (800) 854-3633 with any questions regarding the PCA letter.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Canada

    Quantity

    3,388 kits