BEUDAMED
    FDA Enforcement Class II 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 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2651-2014
    Event ID
    69112
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 25, 2014
    Classification Date
    September 16, 2014
    Termination Date
    February 25, 2015
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    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.

    Code Info

    Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.

    Distribution

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

    Quantity

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