BEUDAMED
    FDA Recall Terminated

    FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit

    Recall: Z-0317-2007 · Initiated October 17, 2006

    Recall

    Recall Number
    Z-0317-2007
    Event Number
    36822
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2006
    Posted
    December 27, 2006
    Terminated
    February 29, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit

    Reason

    The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.

    Action

    A Product Corrective Action (PCA) letter was mailed on Oct 17, 2006 to FC500 MPL and MXP software accounts. They are informed that if the operator opens the Parameter Selection Dialogue box after parameters have been selected for the RATIO Parameter, the selected parameters could revert back to the default choices. If these same parameters were used in the creation of the RATIO Parameter in any other saved protocol, the protocols will also be changed once they are opened after the error occurs. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter. Consignees are asked to complete and return the enclosed Response Form within 10 days.

    Distribution

    Nationwide and Canada

    Quantity

    37 units in the US; 4 units in Canada