BEUDAMED
    FDA Recall Terminated

    Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

    Recall: Z-1377-05 · Initiated July 6, 2005

    Recall

    Recall Number
    Z-1377-05
    Event Number
    32733
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 6, 2005
    Posted
    August 17, 2005
    Terminated
    April 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

    Reason

    Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.

    Action

    Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.

    Distribution

    USA

    Quantity

    36