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  • Dispositivo 1004
  • Fabricante 31827
  • Evento 1040
  • Implante 0
Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Alere INRatio®/Alere INRatio®2 Hematology and Pathology Devices Alere Andorra HA
AQUIOS CL Flow Cytometry System. An in vitro medical device. Hematology and Pathology Devices Beckman Coulter Australia Pty Ltd Australia DHTGA
Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD) Hematology and Pathology Devices Werfen Australia Pty Ltd Australia DHTGA
NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody) Hematology and Pathology Devices Leica Biosystems Melbourne Pty Ltd Australia DHTGA
Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD). Hematology and Pathology Devices Leica Microsystems Pty Ltd Australia DHTGA
Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Inverness Medical Innovations Australia Pty Ltd T/A Alere Australia DHTGA
Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Biomerieux Australia Pty Ltd Australia DHTGA
UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System Hematology and Pathology Devices Beckman Coulter Australia Pty Ltd Australia DHTGA
Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Beckman Coulter Australia Pty Ltd Australia DHTGA
VIDAS D-Dimer Exclusion II (An in vitro medical device (IVD)) Hematology and Pathology Devices Biomerieux Australia Pty Ltd Australia DHTGA
UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Beckman Coulter Australia Pty Ltd Australia DHTGA
UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Beckman Coulter Australia Pty Ltd Australia DHTGA
Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Zoll Medical Australia Pty Ltd Australia DHTGA
Novocastra Liquid Mouse Monoclonal Antibody. An in vitro diagnostic medical device (IVD) Hematology and Pathology Devices Leica Biosystems Melbourne Pty Ltd Australia DHTGA
Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD) Hematology and Pathology Devices Leica Biosystems Melbourne Pty Ltd Australia DHTGA
ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD). Hematology and Pathology Devices Werfen Australia Pty Ltd Australia DHTGA
Trade name: OptiView DAB IHC Detection Kit; Ultraview Universal DAB Detection Kit; OptiView Amplification Kit and Hematoxylin II. Technical Name: Immunohistochemistry - Complementary Reagents. ANVISA Registration Number: 10287410832. Hazard Class: I. Affected Model: N / A .. Serial Numbers Affected :. >> Lots Affected Distributed by Roche Diagnóstica Brazil :. OptiView DAB IHC Detection Kit = Lot Y11625. UltraView Universal DAB Detection Kit = Y09284. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lot Y13938. >> Lots Affected in Stock in Roche Disgnóstica Brazil :. OptiView DAB IHC Detection Kit = Lots Y11625; Y15571; Y19271. ultraView Universal DAB Detection Kit = Lots Y09284; Y11687; Y15384; Y17984; Y18099. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lots Y13938; Y17402; Y17403. NOTE: In the origin (manufacturer) there are other materials and lots affected, but that have not been imported by Brazil so far. Hematology and Pathology Devices Roche Diagnóstica Brasil Ltda.; Ventana Medical Systems, Inc. Brazil ANVISA
Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: Z017KB1MS / Z017LE1MS / Z017MA1MS and Z017NA1MS Hematology and Pathology Devices bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A. Brazil ANVISA
Trade name: InRatio 2 Monitoring System Technical Name: Self-Test for Coagulation Parameters ANVISA Registration Number: 10071770848 Hazard Class: III Model Affected: Monitor InRatio2 Pro / Monitor InRatio2 Hematology and Pathology Devices Alere S.A.; Alere San Diego, Inc. Brazil ANVISA
VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM - ANALYZER WITH COMPUTER Hematology and Pathology Devices BIO-RAD LABORATORIES (CANADA) LTD. Canada HC
HEMOSIL VON WILLEBRAND FACTOR ACTIVITY Hematology and Pathology Devices INSTRUMENTATION LABORATORY CO. Canada HC
NUCLISENS EASYMAG - MAGNETIC SILICA Hematology and Pathology Devices BIOMERIEUX CANADA INC. Canada HC
NOVALIS TX LINEAR ACCELERATOR Hematology and Pathology Devices VARIAN MEDICAL SYSTEMS INC. Canada HC
VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER Hematology and Pathology Devices BIO-RAD LABORATORIES (CANADA) LTD. Canada HC
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