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U.S. Department of Health and Human Services

Class 2 Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge

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  Class 2 Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge see related information
Date Initiated by Firm May 10, 2011
Date Posted August 05, 2011
Recall Status1 Terminated 3 on November 02, 2012
Recall Number Z-2954-2011
Recall Event ID 58043
510(K)Number K974799  K940432  
Product Classification Microcoagulation Systems; Prothrombin Time (PT) - Product Code JPA
Product IL GEM PCL/PCL Plus - Gem Test PT Cartridge
ITC-Nexus Dx

A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
Code Information ID #: 6260030000.  Lot Numbers:  A1ILJPT001, H0ILJPT005, and K0ILJPT006. 
Recalling Firm/
Manufacturer		 International Technidyne Corp.
68 Olsen Ave
Edison NJ 08820-2419
For Additional Information Contact Ms. Ellie Fox
732-548-5700
Manufacturer Reason
for Recall		 Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments.
FDA Determined
Cause 2		 Device Design
Action International Technidyne Corp. (ITC) sent "Urgent Medical Device Recall" letters dated May 10, May 25 and June 09, 2011 to all affected customers. The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement. For questions, please contact ITC Technical Support at (800) 631-5945.
Quantity in Commerce 265 boxes total
Distribution Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
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 = JPA and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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