BEUDAMED
    FDA Recall Terminated

    Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)

    Recall: Z-0566-2007 · Initiated September 12, 2006

    Recall

    Recall Number
    Z-0566-2007
    Event Number
    37287
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 12, 2006
    Posted
    March 6, 2007
    Terminated
    April 19, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)

    Reason

    There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

    Action

    A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.

    Distribution

    Nationwide and Canada

    Quantity

    1893 units in the US; 94 units to Canada