BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2034-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-2034-2017
    Event ID
    76828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 23, 2017
    Classification Date
    May 4, 2017
    Termination Date
    August 22, 2019
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325, United States

    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.

    Code Info

    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867 **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171

    Distribution

    Nationwide, Canada

    Quantity

    3,682 units