BEUDAMED
    FDA Recall Terminated

    Cytomics MXP Software, Version 1.0, Part No. 623688.

    Recall: Z-0636-04 · Initiated February 13, 2004

    Recall

    Recall Number
    Z-0636-04
    Event Number
    28379
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 13, 2004
    Posted
    July 20, 2004
    Terminated
    May 8, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Cytomics MXP Software, Version 1.0, Part No. 623688.

    Reason

    Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

    Action

    Firm sent modified operating instructions to users on 13 February 2004.

    Distribution

    Nationwide and Canada

    Quantity

    7