BEUDAMED
    FDA Recall Terminated

    Coulter AcT 5diff Autoloader (AL) Hematology Analyzer

    Recall: Z-0987-04 · Initiated April 20, 2004

    Recall

    Recall Number
    Z-0987-04
    Event Number
    28957
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2004
    Posted
    July 20, 2004
    Terminated
    September 2, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Coulter AcT 5diff Autoloader (AL) Hematology Analyzer

    Reason

    Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.

    Action

    Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.

    Distribution

    Nationwide and Canada

    Quantity

    70