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U.S. Department of Health and Human Services

Class 2 Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

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  Class 2 Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST see related information
Date Initiated by Firm June 24, 2010
Date Posted July 28, 2010
Recall Status1 Terminated 3 on September 23, 2010
Recall Number Z-2110-2010
Recall Event ID 56114
510(K)Number K904003  
Product Classification assay, heparin - Product Code KFF
Product RQCHRT HRT Control Level 1 & 2;
Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes.
20 vials Whole Blood - 2.0mL; dried
20 vials Diluent - 4.0 mL

The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
Code Information Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
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		 An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.
FDA Determined
Cause 2		 Other
Action ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.
Quantity in Commerce 38 in US, 3 Out of US
Distribution Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
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 = KFF and Original Applicant = INTENSIVE TECHNOLOGY, INC.
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