BEUDAMED
    FDA Recall Terminated

    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

    Recall: Z-0455-2009 · Initiated August 1, 2007

    Recall

    Recall Number
    Z-0455-2009
    Event Number
    49010
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 1, 2007
    Posted
    January 7, 2009
    Terminated
    January 13, 2009
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

    Reason

    Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa

    Action

    The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.

    Distribution

    Globally to the United States and Canada.

    Quantity

    565