BEUDAMED
    FDA Recall Terminated

    SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

    Recall: Z-2238-2009 · Initiated October 22, 2007

    Recall

    Recall Number
    Z-2238-2009
    Event Number
    48191
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    DKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 22, 2007
    Posted
    September 30, 2009
    Terminated
    July 16, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

    Reason

    The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.

    Action

    An "Urgent: Product Corrective Action" letter dated October 22, 2007 was issued to customers. Customers were instructed to do the following: 1) Discontinue use and discard appropriately the affected lots of Salicylate Reagent., 2) Contact your Customer Service Representatives at 1-800-526-3821 in the United States or local Beckman Coulter Representative to discuss replacement options and 3) Complete and return the enclosed response form within 10 days. Contact your Customer Service Representative at 1-800-526-3821 in the United States or 1-800-463-7828 in Canada or, if you are outside the United States or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. Direct any questions regarding this Product Corrective Action letter to the Customer Support Center (Hotline) at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, please contact your local Beckman Coulter Representative.

    Distribution

    Nationwide and Canada.

    Quantity

    7,842 total