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U.S. Department of Health and Human Services

Class 2 Device Recall International Technidyne Corporation

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  Class 2 Device Recall International Technidyne Corporation see related information
Date Initiated by Firm December 19, 2013
Date Posted February 06, 2014
Recall Status1 Terminated 3 on October 30, 2014
Recall Number Z-0937-2014
Recall Event ID 67237
510(K)Number K014008  
Product Classification Activated partial thromboplastin - Product Code GFO
Product Hemochron Jr. Citrate APTT Cuvette
510(k) K014008
A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
Code Information E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
Recalling Firm/
ITC-Nexus Dx
23 Nevsky St
Edison NJ 08820-2425
Manufacturer Reason
for Recall
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
FDA Determined
Cause 2
Device Design
Action The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, remove from inventory and return to ITC; complete the attached Health Professional Account Tracking Form and return it within 10 days via fax to: 866-429-3132, email: RA@itcmed.com or mail to: ITC Technical Support, 20 Corporate Place South - Piscataway, NJ 08854 . It is important that you complete the form whether or not you have remaining inventory of these lots. In addition, contact ITC Technical Support immediately if you become aware of an unreported adverse event related to the use of affected J103C cuvettes. ITC will review your response form and will contact you to arrange for any inventory to be returned to ITC and ITC will replace all unused, returned product. If you have questions, please contact ITC Technical Support: Telephone 800-579-2255 or 732-548-5700, Extension 4011 or E-mail Techsupport@itcmed.com.
Quantity in Commerce 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Distribution Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
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.
510(K) Database 510(K)s with Product Code = GFO and Original Applicant = ITC, INC.