Company: International Technidyne Corp
Date of Enforcement Report 11/10/2010
Class lll:

PRODUCT
Integrated Data Management System – Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010

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.

RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter dated March 10, 2010. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
84 idms software systems

DISTRIBUTION
Nationwide, Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand