BEUDAMED
    FDA Recall Terminated

    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated differential cell counter; Part Number 722398; Beckman Coulter; Miami, FL 33196.

    Recall: Z-2021-2008 · Initiated May 4, 2007

    Recall

    Recall Number
    Z-2021-2008
    Event Number
    46287
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 4, 2007
    Posted
    July 11, 2008
    Terminated
    July 11, 2011
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated differential cell counter; Part Number 722398; Beckman Coulter; Miami, FL 33196.

    Reason

    Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.

    Action

    Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.

    Distribution

    Worldwide Distribution including USA and country of Canada.

    Quantity

    445 units in the US; 56 units in Canada