BEUDAMED
    FDA Recall Terminated

    COULTER LH 750 Hematology Analyzer.

    Recall: Z-0536-05 · Initiated December 16, 2004

    Recall

    Recall Number
    Z-0536-05
    Event Number
    30732
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2004
    Posted
    February 10, 2005
    Terminated
    April 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    COULTER LH 750 Hematology Analyzer.

    Reason

    A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.

    Action

    Letter 12/20/04 A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation''s database are not affected. If the LH750 instrument displays a pop-up winder titled Database Error (XXXXXX) and text similar to (Microsoft) (ODBC SQL...) As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Do not acknowledge the error. Instead, restart the entire system by completely powering it OFF and then ON. Or, if the LH750 Workstation experiences a change in performance, such as screen display freezes, slow response time, or requires frequent resets to continue processing. As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Verify the accuracy of all patient reports for the samples until service confirms the performance of system.

    Distribution

    US and Canada

    Quantity

    1,257