Events

Recall of Integrated Data Management System Version 7.1, 7.2 and 7.3;

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Technidyne Corporation.

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
    55427
  • Event Risk Class
    Class 3
  • Event Number
    Z-2438-2010
  • Event Initiated Date
    2010-04-09
  • Event Date Posted
    2010-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90826
  • 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
    A tabulation error in the integrated data management systems (idms) data management software that results in incorrect electronic quality control (eqc) summary reports: the operator and the device performance summary reports. the idms software is not used for the clinical management of individual patients.
  • Action
    ITC sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 10, 2010 to Distributors and First Consignee End Users identifying the affected product and affected summary reports, the reason for recall, and the actions to be taken by the distributors and customers. New Errata Instructions were enclosed with each letter and are to be put in the idms user guide for reference. The new instructions are to be followed when running reports for the ESV or TVT tests run by the Hemochron Response. The enclosed Customer Account Tracking Form is to be completed and returned to ITC indicating that the letter has been received and appropriate questions answered as to the use of the software system. Distributors are asked to check inventory for recalled product. If affected product is found, shipment should be stopped and placed on hold. Distributors should notify customers of the correction and provide them with a copy of the correction letter and updated instructions. This should be done by traceable mail. Distributors should return the account tracking form and return affected software disks for replacement. Questions should be directed to ITC Technical Support at 800-631-5945.

Device

Integrated Data Management System Version 7.1, 7.2 and 7.3;
  • Model / Serial
    Product code 464100, Version numbers 7.1.0, 7.2.0 and 7.3.0.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA, TN , TX, UT, VA, WA, and WI, and the countries of Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand.
  • Product Description
    Integrated Data Management System - Version 7.1, 7.2 and 7.3; || ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Manufacturer Address
    International Technidyne Corporation, 23 Nevsky St, Edison NJ 08820-2425
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA