Class 2 Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)

• Date Initiated by Firm: November 30, 2010
• Date Posted: February 11, 2011
• Recall Status: Terminated on August 22, 2012
• Recall Number: Z-1093-2011
• Recall Event ID: 57405
• 510(K)Number: K983475
• Product Classification: Coagulation Instrument - Product Code KQG
• Product: Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.
• Code Information: Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
• Recalling Firm/ Manufacturer: International Technidyne Corp.; 6-8 Olsen Avenue; Edison NJ 08820-2419
• For Additional Information Contact: Larry Picciano; 732-548-5700 Ext. 4451
• Manufacturer Reason for Recall: Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
• FDA Determined Cause: Process control
• Action: ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail techsupport@itcmed.com.
• Quantity in Commerce: 265 boxes (95 ACT Tubes per box)
• Distribution: Worldwide Distribution
• 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 = KQG