BEUDAMED
    FDA Recall 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 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-1680-2017
    Event Number
    76036
    Firm
    Data Innovations, LLC
    FEI Number
    3001451449
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 23, 2014
    Posted
    February 16, 2017
    Terminated
    August 21, 2019
    Address
    120 Kimball Ave, Ste 100, South Burlington, VT, 05403-6837

    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.

    Action

    Data Innovations, LLC contacted consignees by phone, email, and post. Recall notifications were sent out on November 3, 2014. Consignees were provided instructions on how to reconfigure the drive to work around the issue. If consignees were unable to perform the work around, Customer Support is able to service the units. In order to request this service, consignees were to call 239-931-6004, 802-658-1955, or 800-332-0499. Attached to the recall notification was a response form that is to be faxed to 802-658-2782. Consignees with and without affected drives are to complete this response form. For questions regarding this recall call 239-931-6004.

    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