BEUDAMED
    FDA Enforcement Class II Terminated

    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Recall: Z-0256-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0256-2013
    Event ID
    62580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    June 1, 2012
    Classification Date
    November 6, 2012
    Termination Date
    August 22, 2016
    Address
    1 Nelson C White Pkwy, N/A, Mundelein, IL, 60060-9528, United States

    Description

    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Reason

    There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.

    Code Info

    catalog ##053-2311-4, all serial numbers

    Distribution

    Nationwide distribution: USA including Puerto Rico.

    Quantity

    69 units