Z-2438-2010

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

Name: Z-2438-2010 Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South...
Creator: International Technidyne Corporation
Published: 2010-04-09
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2010-04-09 / Terminated / root cause: software

FDA source

International Technidyne Corporation began a recall of Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854 on 2010-04-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2438-2010
Status: Terminated
Initiated: 2010-04-09
Posted: 2010-09-20
Terminated: 2011-05-25
Recalling firm: Accriva Diagnostics, Inc.
Product: Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Product code 464100, Version numbers 7.1.0, 7.2.0 and 7.3.0.

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)