BEUDAMED
    FDA Recall Terminated

    Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1

    Recall: Z-0197-2007 · Initiated July 26, 2006

    Recall

    Recall Number
    Z-0197-2007
    Event Number
    36397
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 26, 2006
    Posted
    November 21, 2006
    Terminated
    February 29, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1

    Reason

    Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.

    Action

    Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.

    Distribution

    Nationwide and Canada

    Quantity

    416 (US) + 60 (Canada)