BEUDAMED
    FDA Recall Terminated

    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.

    Recall: Z-2651-2014 · Initiated August 25, 2014

    Recall

    Recall Number
    Z-2651-2014
    Event Number
    69112
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GIF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 25, 2014
    Posted
    September 16, 2014
    Terminated
    February 25, 2015
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.

    Reason

    Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.

    Action

    Beckman Coulter sent an Urgent Medical Device Recall letter dated August 25, 2014, to all customers that purchased the Coulter DxH Diluent. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com, or call (800) 526-7694 in the US and Canada.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .

    Quantity

    46,050 units total (40,078 units in US)