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U.S. Department of Health and Human Services

Class 3 Device Recall Integrated Data Management System Version 7.1, 7.2 and 7.3;

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  Class 3 Device Recall Integrated Data Management System Version 7.1, 7.2 and 7.3; see related information
Date Initiated by Firm April 09, 2010
Date Posted September 20, 2010
Recall Status1 Terminated 3 on May 25, 2011
Recall Number Z-2438-2010
Recall Event ID 55427
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Integrated Data Management System - Version 7.1, 7.2 and 7.3;
ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
Code Information Product code 464100, Version numbers 7.1.0, 7.2.0 and 7.3.0.
Recalling Firm/
Manufacturer		 International Technidyne Corporation
23 Nevsky St
Edison NJ 08820-2425
For Additional Information Contact Larry Picciano
732-548-5700 Ext. 4451
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 84 total idms software systems; 66 in US, 18 outside of US.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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