Events

Recall of Device Recall Instrument Manager software

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
    52105
  • Event Risk Class
    Class 2
  • Event Number
    Z-0083-2012
  • Event Initiated Date
    2009-05-11
  • Event Date Posted
    2011-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82110
  • 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
    The "previous result" retrieved from the specimen management database may not be the most recent "previous result".
  • Action
    Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.

Device

Device Recall Instrument Manager software
  • Model / Serial
    S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) and the country of Canada.
  • Product Description
    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. || It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
  • 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