BEUDAMED
    FDA Recall Terminated

    Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834

    Recall: Z-0959-2008 · Initiated June 29, 2007

    Recall

    Recall Number
    Z-0959-2008
    Event Number
    45945
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 29, 2007
    Posted
    April 30, 2008
    Terminated
    December 13, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834

    Reason

    Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

    Action

    Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.

    Distribution

    Worldwide Distribution- USA and country of Canada.

    Quantity

    516 units in the US; 73 units in Canada