BEUDAMED
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    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

    directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.

    FDA Recall
    Terminated ·International Technidyne Corporation·Product code GGN·April 15, 2010

    Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator

    FDA Recall
    Terminated ·Capintec Inc·Product code KPT·July 8, 2011

    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

    BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·November 20, 2007

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Recall
    Terminated ·Capintec Inc·Product code IZD·March 3, 2020

    BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·November 20, 2007

    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·March 5, 2012

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code JCA·August 22, 2013

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·May 1, 2013

    BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMI·October 5, 2010

    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

    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

    Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.

    FDA Recall
    Terminated ·Capintec Inc·Product code IZD·July 24, 2012

    HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.

    FDA Recall
    Terminated ·ITC-Nexus Dx, Inc.·Product code GKR·January 21, 2011

    Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854

    FDA Recall
    Terminated ·International Technidyne Corporation·Product code JQP·April 9, 2010

    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