BEUDAMED
    FDA Enforcement Class II Terminated

    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004

    Recall: Z-0571-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0571-2014
    Event ID
    66754
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Data Innovations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2014
    Initiation Date
    November 6, 2013
    Classification Date
    December 24, 2013
    Termination Date
    December 5, 2014
    Address
    120 Kimball Ave Ste 100, N/A, South Burlington, VT, 05403-6837, United States

    Description

    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004

    Reason

    When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may result in sample error

    Code Info

    Software alll versions prior to: v7.00.0006 and v8.00. Includes: v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004

    Distribution

    Nationwide Canada and Britain

    Quantity

    24 systems