Class 2 Device Recall directCheck

• Date Initiated by Firm: June 25, 2010
• Date Posted: August 10, 2010
• Recall Status: Terminated on September 23, 2010
• Recall Number: Z-2200-2010
• Recall Event ID: 56117
• 510(K)Number: K944691
• Product Classification: plasma control in vitro diagnostic - Product Code GGN
• Product: International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
• Code Information: Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
• FEI Number: 1000526865
• 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: The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
• FDA Determined Cause: Nonconforming Material/Component
• Action: ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.
• Quantity in Commerce: 122 boxes in US, 1 out of US.
• Distribution: Nationwide and one customer in Belgium.
• 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 = GGN