BEUDAMED
    FDA Recall Terminated

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    Recall: Z-1951-2013 · Initiated September 22, 2010

    Recall

    Recall Number
    Z-1951-2013
    Event Number
    65655
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2010
    Posted
    August 10, 2013
    Terminated
    August 10, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    Reason

    Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.

    Action

    Beckman Coulter Inc sent an Urgent Product Corrective Action (PCA) letter dated September 22, 2010 to all affected customers. Customers were notified of the the problems identified and the actions to be completed. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and in Canada.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom

    Quantity

    718 units total (132 units in US)