BEUDAMED
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    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

    CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JPA·March 12, 2003

    ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·November 11, 2010

    ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·November 11, 2010

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code JPA·June 20, 2014

    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·January 26, 2015

    CoaguChek PT test strips, sold in 12 pack.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JPA·February 20, 2003

    ACL Futura Instrument Analyzer

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·March 4, 2004

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JPA·June 15, 2012

    The MDA system with MDA Antithrombin III MDA Heparin

    FDA Recall
    Terminated ·bioMerieux·Product code JPA·June 11, 2004

    Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code JPA·March 8, 2010

    Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems International, Inc., Rockville, MD 20855

    FDA Recall
    Terminated ·Inotech Biosystems Intl., Inc·Product code JPA·August 20, 2007

    TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System

    FDA Recall
    Terminated ·Haemoscope Division of Haemonetics Corp·Product code JPA·March 4, 2011

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    FDA Recall
    Terminated ·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·Product code JPA·April 22, 2016

    TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·February 19, 2020

    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·April 26, 2022

    ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code JPA·November 11, 2010

    TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies

    FDA Recall
    Terminated ·Haemoscope Division of Haemonetics Corp·Product code JPA·January 28, 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

    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code JPA·September 13, 2016