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U.S. Department of Health and Human Services

Class 2 Device Recall directCHECK Whole Blood Control

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  Class 2 Device Recall directCHECK Whole Blood Control see related information
Date Initiated by Firm April 15, 2010
Date Posted June 11, 2010
Recall Status1 Terminated 3 on September 23, 2010
Recall Number Z-1786-2010
Recall Event ID 55404
510(K)Number K944691  
Product Classification Plasma, coagulation control - Product Code GGN
Product directCHECK Whole Blood Control;
for Hemochron J. Microcoagulation Systems.
Code Information Catalog number.Code number: DCJPT-A; Lot number G9DPA005; Exp. 1/31/2011.
Recalling Firm/
Manufacturer		 International Technidyne Corporation
23 Nevsky St
Edison NJ 08820-2425
For Additional Information Contact Larry Picciano
732-548-5700 Ext. 4451
Manufacturer Reason
for Recall		 Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.
FDA Determined
Cause 2		 Error in labeling
Action Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.
Quantity in Commerce 94 boxes
Distribution Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi 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 = GGN and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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