BEUDAMED
    FDA Recall Terminated

    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

    Recall: Z-2034-2017 · Initiated March 23, 2017

    Recall

    Recall Number
    Z-2034-2017
    Event Number
    76828
    Firm
    Sysmex America Inc
    FEI Number
    3009711478
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 23, 2017
    Posted
    April 14, 2017
    Terminated
    August 22, 2019
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

    Reason

    Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.

    Action

    Sysmex sent an Field Correction letter dated April 2017. Product will not be returned, but corrected at the customer site. The correction requires a service visit that will be documented in the Sysmex service Customer Relationship Management (CRM) software. The service report is accepted by the customer at the time of service. Completion of the service records will be tracked by reports generated from the Service CRM. For further Technical Assistance or questions please call (1 888) 879-7639.

    Distribution

    Nationwide, Canada

    Quantity

    3,682 units