Events

Recall of JResultNet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Data Innovations, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76036
  • Event Risk Class
    Class 2
  • Event Number
    Z-1680-2017
  • Event Initiated Date
    2014-10-23
  • Event Date Posted
    2017-02-16
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152016
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • 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.

Device

JResultNet
  • Model / Serial
    All drive versions were affected.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
    Data Innovations, LLC

Manufacturer

Data Innovations, LLC
  • Manufacturer Address
    Data Innovations, LLC, 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA