BEUDAMED
    FDA Enforcement Class II Terminated

    JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information

    Recall: Z-1680-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1680-2017
    Event ID
    76036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Data Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 5, 2017
    Initiation Date
    October 23, 2014
    Classification Date
    March 24, 2017
    Termination Date
    August 21, 2019
    Address
    120 Kimball Ave Ste 100, South Burlington, VT, 05403-6837, United States

    Description

    JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information

    Reason

    Software issue resulting in the results of one patient potentially being associated with another.

    Code Info

    All drive versions were affected.

    Distribution

    Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & DC.

    Quantity

    657 units