BEUDAMED
    FDA Recall 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 · Initiated November 6, 2013

    Recall

    Recall Number
    Z-0571-2014
    Event Number
    66754
    Firm
    Data Innovations, Inc.
    FEI Number
    3001451449
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 6, 2013
    Posted
    December 24, 2013
    Terminated
    December 5, 2014
    Address
    120 Kimball Ave, Ste 100, South Burlington, VT, 05403-6837

    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

    Action

    Data Innovation notified consignees by Important Medical Device Recall Notification dated 11/5/13 to all list serv recipients of the problem and posted critical alert on Customer Web Portal. A certified letter was issued to impacted customers and consignees if no response was recieved from e-mail.

    Distribution

    Nationwide Canada and Britain

    Quantity

    24 systems