BEUDAMED
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    HEMOCHRON JR. PT CUVETTE

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GJS·January 17, 2012

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Injury ·INTERNATIONAL TECHNIDYNE CORP·Product code DSQ·September 1, 2010

    AVOXIMETER 1000E

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP·Product code DQA·June 10, 2011

    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

    DIRECTCHECK QUALITY CONTROL

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GGN·July 15, 2015

    HEMOCHRON RESPONSE, 110V

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·July 10, 2015

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·March 20, 2012

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GJS·January 24, 2012

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·February 13, 2012

    HEMOCHRON JR SIGNATURE SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code JPA·February 20, 2012

    DIRECT CHECK QUALITY CONTROL

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GGN·March 26, 2012

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·March 7, 2012

    DIRECT CHECK QUALITY CONTROL

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GGN·March 16, 2012

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·February 15, 2012