Events

Recall of Data Innovations

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

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
    36508
  • Event Risk Class
    Class 2
  • Event Number
    Z-0167-2007
  • Event Initiated Date
    2006-08-10
  • Event Date Posted
    2006-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48777
  • 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
    Instrument Manager - Product Code JQP
  • Reason
    Patient results may be associated with an incorrect specimen.
  • Action
    Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.

Device

Data Innovations
  • Model / Serial
    Software Versions:  8:00, 8.01, 8.02, 8.03 or 8.04
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution (USA and Canada)
  • Product Description
    Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
  • Manufacturer
    Data Innovations, Inc.

Manufacturer

Data Innovations, Inc.
  • Manufacturer Address
    Data Innovations, Inc., 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Source
    USFDA