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U.S. Department of Health and Human Services

Class 2 Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

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  Class 2 Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System see related information
Date Initiated by Firm March 31, 2010
Date Posted March 01, 2011
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-0893-2011
Recall Event ID 54768
Product Classification Upc Reader (bar code reader) - Product Code RFZ
Product Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System.

The system is intended to be used only with test cuvettes that are available from ITC.
Code Information Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
Recalling Firm/
International Technidyne Corp.
6-8 Olsen Avenue
Edison NJ 08820-2419
For Additional Information Contact ITC TEch Support
732-548-5700 Ext. 4700
Manufacturer Reason
for Recall
There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner.
FDA Determined
Cause 2
Labeling mix-ups
Action Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.
Quantity in Commerce 1640 units (1303 US, 337 foreign)
Distribution Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
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.