BEUDAMED
    FDA Recall Terminated

    Cytomics FC500 with CXP Software

    Recall: Z-0380-06 · Initiated November 23, 2005

    Recall

    Recall Number
    Z-0380-06
    Event Number
    34247
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJF
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    November 23, 2005
    Posted
    January 11, 2006
    Terminated
    January 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC500 with CXP Software

    Reason

    Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0

    Action

    A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.

    Distribution

    Nationwide and Canada

    Quantity

    179