16 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
FDA Recall
Terminated
·International Technidyne Corp.·Product code DQA·February 13, 2008
International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
FDA Recall
Terminated
·International Technidyne Corp.·Product code JKS·February 13, 2008
International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
FDA Recall
Terminated
·International Technidyne Corp.·Product code DQA·February 13, 2008
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
FDA Enforcement
Class II
·Terminated·International Technidyne Corp.·February 27, 2013
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JBP·April 27, 2005
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
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.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
FDA Recall
Terminated
·International Technidyne Corp·Product code FMK·January 23, 2006
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.
FDA Recall
Terminated
·International Technidyne Corp.·Product code KQG·November 30, 2010
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
FDA Recall
Terminated
·International Technidyne Corp.·Product code DQA·March 23, 2011
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
FDA Recall
Terminated
·International Technidyne Corp.·Product code GJS·September 28, 2012
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.
FDA Recall
Terminated
·International Technidyne Corp.·Product code KFF·June 24, 2010
Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JBP·May 5, 2009
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.
FDA Recall
Terminated
·International Technidyne Corp.·Product code GGN·June 25, 2010
Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cuvettes that are available from ITC.
FDA Recall
Terminated
·International Technidyne Corp.·Product code RFZ·March 31, 2010
International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.
FDA Recall
Terminated
·International Technidyne Corp.·Product code GJS·December 6, 2006