BEUDAMED
    FDA Recall Terminated

    Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854

    Recall: Z-2438-2010 · Initiated April 9, 2010

    Recall

    Recall Number
    Z-2438-2010
    Event Number
    55427
    Firm
    International Technidyne Corporation
    FEI Number
    2250033
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 9, 2010
    Posted
    September 20, 2010
    Terminated
    May 25, 2011
    Address
    23 Nevsky St, Edison, NJ, 08820-2425

    Description

    Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854

    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.

    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.

    Quantity

    84 total idms software systems; 66 in US, 18 outside of US.