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  • Dispositivo 3309
  • Fabricante 731
  • Evento 124969
  • Implante 166
Cell-Dyn Emerald Cleanser
  • Modelo / Serial
  • Descripción del producto
    IVD Other
  • Manufacturer
    Abbot Laboratories
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Cell-Dyn Emerald Cleanser
ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
  • Modelo / Serial
    3P24-25
  • Descripción del producto
    DETERMINATION OF THE ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
Architect Total PSA Reagent kit
  • Modelo / Serial
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTIC DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para Architect Total PSA Reagent kit
ARCHITECT SHBG REAGENT KIT
  • Modelo / Serial
  • Descripción del producto
    CONTROL, CALIBRATION AND QUANTITATIVE DETERMINATION OF INSULIN, GLOBULINE IN THE BLOCKING OF SEXUAL HORMONES AND HORMONE PARATIROIDEA IN SERUM AND PLASMAHUMANS RESPECTIVELY.
  • Manufacturer
    ABBOTT LABORATORIES DIVISION DIAGNOSTICS || ABBOTT LABORATORIES JAPAN CO. LTD. || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Alerta De Seguridad para ARCHITECT SHBG REAGENT KIT
REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
  • Modelo / Serial
    Reference 04N66-90 Lots: All.
  • Descripción del producto
    IN VITRO AMPLIFICATION TEST FOR QUALITATIVE LADETECTION OF NUCLEIC ACIDS OF THE HUMAN IMMUNODEFICIENCY VIRUS DET 1 (HIV - 1) IN PLASMA AND YANGAN SECA HUMAN SAMPLES.
  • Manufacturer
    ABBOTT GMBH & CO KG /ABBOTT MOLECULAR, INC || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
  • Modelo / Serial
    List Number (LN): 8L44-10, lot 54570LI00.
  • Descripción del producto
    IMMUNOANALYSIS CHIMIOLUMINISCENTE DE MICROPARTICULAS (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES AGAINST THE ANTIGENOCORE OF HEPATITIS B VIRUS (ANTI HBC) HUMAN PLASMA AND PLASMA, INCLUDING POST-MORTEM RENEWED SAMPLES (WITHOUT CARDIAC TREATMENT).
  • Manufacturer
    ABBOTT GMBH & CO KG || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Alerta De Seguridad para ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
Alinity I Processing Module ABBOTT
  • Modelo / Serial
    ALINITY CI-SERIES MODULE, all serials.
  • Descripción del producto
    It is a fully automated immunoassay system that allows random and continuous access, as well as priority processing and automatic re-analysis using chemoluminescent micro-particle immunoassay technology. CMIA technology is used to determine the presence of antigens, antibodies and analytes in samples. The scalable design of the ALINITY I allows one or more sample processing modules, in multiple configurations, with a system control module to physically join together to form a single workstation.
  • Manufacturer
    Abbott Gmbh & Co. Kg
  • 2 Events
    • Alerta De Seguridad para Alinity I Processing Module ABBOTT
    • Alerta De Seguridad para Alinity I Processing Module ABBOTT
ARCHITECT Toxo IgM
  • Modelo / Serial
  • Descripción del producto
    IMMUNOANALYSIS CHIMIOLUMINISCENT OF MICROPARTICLES (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES IgM FRONT SToxoplasma gondii in SERUM AND HUMAN PLASMA.
  • Manufacturer
    ABBOTT GmbH&Co KG || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Alerta De Seguridad para ARCHITECT Toxo IgM
ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
  • Modelo / Serial
    Reference: 2P13-28, lot: 10458UP00
  • Descripción del producto
    DETERMINATION, CALIBRATION AND CONTROL OF THE TESTOSTERONE TEST IN SERUM AND PLASMAHUMAN
  • Manufacturer
    ABBOTT GMHBH & CO. KG || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
ARCHITECT STAT High Sensitive Troponin-I
  • Modelo / Serial
    Ref: 3P25-26 || Lot: 56940UI00
  • Descripción del producto
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION.
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Alerta De Seguridad para ARCHITECT STAT High Sensitive Troponin-I
Alinity I HBsAg calibrators
  • Modelo / Serial
    08P0801 Lot:3313FN00
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para Alinity I HBsAg calibrators
ARCHITECT FREE T4 REAGENT
  • Modelo / Serial
  • Descripción del producto
    QUANTITATIVE DETERMINATION OF TRIYODOTIRONIN T3 AND TORIXIN T4 IN SERUM AND PLASMA TO HUMANS.
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Imported by: ABBOTT LABORATORIES DE || COLOMBIA S.A.
  • 1 Event
    • Alerta De Seguridad para ARCHITECT FREE T4 REAGENT
HEMOGLOBIN A1C CALIBRATORS
  • Modelo / Serial
  • Descripción del producto
    Determination of the different analytes related to samples from the human organism.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Alerta De Seguridad para HEMOGLOBIN A1C CALIBRATORS
HEMOGLOBIN A1C REAGENT KIT
  • Modelo / Serial
    REF: 4P52-21 || LOTS: 50279UQ12, 50280UQ12, 50282UQ12, || 50613UQ02, 50614UQ02, 50615UQ02, 50884UQ04, || 50281UQ12, 50615UQ02, 51177UQ06, 50279UQ12, || 50280UQ12, 50031UQ10, 50007UQ10, 50281UQ12.
  • Descripción del producto
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED WITH SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ABBOTT LABORATORIES || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Alerta De Seguridad para HEMOGLOBIN A1C REAGENT KIT
ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
  • Modelo / Serial
    Reference. 9D31-20 Lot. 45059UN14
  • Manufacturer
    Abbott Laboratories de Colombia S.A.
  • 1 Event
    • Alerta De Seguridad para ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
Multichem S Plus (Assayed) Level 2
  • Modelo / Serial
    Reference: 5P78-11. Lot13811132
  • Descripción del producto
    Determination of analytes related to samples from the human organism
  • Manufacturer
    Abbott Laboratories de Colombia S.A. Brand. Technopath
  • 1 Event
    • Alerta De Seguridad para Multichem S Plus (Assayed) Level 2
ICT SERUM CALIBRATOR
  • Modelo / Serial
  • Descripción del producto
    Quantitative determination of the related analytes in samples from the Human organism.
  • Manufacturer
    Abbott Laboratories Division Diagnostics Usa
  • 1 Event
    • Alerta De Seguridad para ICT SERUM CALIBRATOR
ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
  • Modelo / Serial
  • Descripción del producto
    Control, calibration and quantitative determination of insulin, binding globulin of sex hormones and parathyroid hormone in human serum and plasma respectively.
  • Manufacturer
    Abbott Laboratories Division Diagnostics Usa.
  • 1 Event
    • Alerta De Seguridad para ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
Chemiluminescent immunoanalysis - Anti-HB II
  • Modelo / Serial
    Reference. 8L4425 Lots: 42072LI00, 42072LI01, 42253LI00, 42253LI01, Reference.8L44-30 Lots 42255LI00, 4225LI01, Reference. 8L44-35 Lot 42256LI00
  • Descripción del producto
    Chemiluminescent immunoanalysis of macroparticles for the qualitative detection of antibodies against the CORE antigen of Hepatitis B virus (ANTI HBC) in serum and human plasma including samples collected POSTMORTEM
  • Manufacturer
    ABBOTT LABORATORIOS
  • 1 Event
    • Alerta De Seguridad para Chemiluminescent immunoanalysis - Anti-HB II
ABBOTT REAL TIME HIV 1 - REAGENT KIT
  • Modelo / Serial
    Lot: 462605
  • Descripción del producto
    Quantitative determination of Human Immunodeficiency Virus type 1 in human plasma of patients infected by HIV 1
  • Manufacturer
    ABBOTT MOLECULAR INC || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para ABBOTT REAL TIME HIV 1 - REAGENT KIT
REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Modelo / Serial
  • Descripción del producto
    REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Manufacturer
    ABBOTT MOLECULAR INC. || Imported by: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Alerta De Seguridad para REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
Coronary Dilatation Catheter NC Trek
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Catheters for coronary dilatation are used for: 1. Balloon dilatation of the stenotic portion of a coronary artery from the stenosis of a bypass graft in order to improve myocardial perfusion. 2. Balloon dilatation of an occlusion in a coronary artery, in order to restore coronary flow in cases of myocardial infarction with ST-segment elevation. 3. Dilation with balloon of a stent after implanting it (balloon models from 2.00 mm to 5.00 mm only).
  • Manufacturer
    Abbott Vascular
  • 1 Event
    • Alerta De Seguridad para Coronary Dilatation Catheter NC Trek
Endovascular closure STARCLOSE SE ABBOTT
  • Modelo / Serial
  • Descripción del producto
    Endovascular closure device designed for the closure of the femoral artery after percutaneous catheterization procedures.
  • Manufacturer
    Abbott Vascular
  • 1 Event
    • Alerta De Seguridad para Endovascular closure STARCLOSE SE ABBOTT
Abon - syphilis ultra rapid test (whole blood/serum/plasma)
  • Modelo / Serial
    ISY-U411 Lot: SYP8010030
  • Manufacturer
    ABON BIOPHARM || Importer: ALERE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para Abon - syphilis ultra rapid test (whole blood/serum/plasma)
Abon HCG
  • Modelo / Serial
    FHC-201. Lot HCG7070054.
  • Manufacturer
    ABON BIOPHARM || Importer: ALERE COLOMBIA S.A
  • 1 Event
    • Alerta De Seguridad para Abon HCG
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