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  • Device 1608
  • Manufacturer 1608
  • Event 1666
  • Implant 0
Steam Indicator Tape 1322
  • Model / Serial
  • Product Description
    Use the steam indicator tape to demonstrate that the packages taken to steam sterilization processes have been exposed to the process and to distinguish between processed and unprocessed packaging.
  • Manufacturer
    3M Canada Company || 3M Health Care
  • 1 Event
    • Safety Alert for Steam Indicator Tape 1322
Temperature Monitoring System
  • Model / Serial
    Bair Hugger 36000 and SpotOn reference sensors,
  • Product Description
    The SPOTON temperature control system is a direct thermometer that uses the zero-flow thermometry-heat technique to produce an accurate estimate of the temperature of deep tissue in a person. SPOTON is used to measure, monitor, and supply the body temperature trend of adult and pediatric patients.
  • Manufacturer
    3M Company || 3M Health Care
  • 1 Event
    • Safety Alert for Temperature Monitoring System
Adhesives and Primers 3M UNITEK
  • Model / Serial
    704-055, specific lots.
  • Product Description
    Adhesive to be used in the adhesion of orthodontic treatment systems such as brackets, retainers, bands.
  • Manufacturer
    3M Espe Dental Products || 3M Deutschland Gmbh || 3M Unitek Corporation
  • 1 Event
    • Safety Alert for Adhesives and Primers 3M UNITEK
System for Fluid Heating RANGER 245
  • Model / Serial
    RANGER 245
  • Product Description
    The RANGER heating system is designed to heat blood, blood products and liquids. The heating system for blood and fluids RANGER is a device composed of a heating unit and a disposable equipment for the administration of blood and fluids intravenously (IV), the heating system RANGER is designed to heat blood, blood products and liquids and achieves a speed of MVA flow rate at 500ml per minute. Two disposable equipment for blood and fluids can be obtained: one for normal flow applications and one for high flow applications. These disposable equipment, designed for use in reusable dewaxing units, are sterilized, do not contain latex and are for single use only.
  • Manufacturer
    3M Health Care
  • 1 Event
    • Safety Alert for System for Fluid Heating RANGER 245
ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
  • Model / Serial
    3P24-25
  • Product Description
    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
    • Safety Alert for ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
Architect Total PSA Reagent kit
  • Model / Serial
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTIC DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Architect Total PSA Reagent kit
ARCHITECT SHBG REAGENT KIT
  • Model / Serial
  • Product Description
    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
    • Safety Alert for ARCHITECT SHBG REAGENT KIT
REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
  • Model / Serial
    Reference 04N66-90 Lots: All.
  • Product Description
    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
    • Safety Alert for REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
  • Model / Serial
    List Number (LN): 8L44-10, lot 54570LI00.
  • Product Description
    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
    • Safety Alert for ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
Alinity I Processing Module ABBOTT
  • Model / Serial
    ALINITY CI-SERIES MODULE, all serials.
  • Product Description
    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
    • Safety Alert for Alinity I Processing Module ABBOTT
    • Safety Alert for Alinity I Processing Module ABBOTT
ARCHITECT Toxo IgM
  • Model / Serial
  • Product Description
    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
    • Safety Alert for ARCHITECT Toxo IgM
ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
  • Model / Serial
    Reference: 2P13-28, lot: 10458UP00
  • Product Description
    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
    • Safety Alert for ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
ARCHITECT STAT High Sensitive Troponin-I
  • Model / Serial
    Ref: 3P25-26 || Lot: 56940UI00
  • Product Description
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION.
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Safety Alert for ARCHITECT STAT High Sensitive Troponin-I
Alinity I HBsAg calibrators
  • Model / Serial
    08P0801 Lot:3313FN00
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Alinity I HBsAg calibrators
ARCHITECT FREE T4 REAGENT
  • Model / Serial
  • Product Description
    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
    • Safety Alert for ARCHITECT FREE T4 REAGENT
HEMOGLOBIN A1C CALIBRATORS
  • Model / Serial
  • Product Description
    Determination of the different analytes related to samples from the human organism.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Safety Alert for HEMOGLOBIN A1C CALIBRATORS
HEMOGLOBIN A1C REAGENT KIT
  • Model / Serial
    REF: 4P52-21 || LOTS: 50279UQ12, 50280UQ12, 50282UQ12, || 50613UQ02, 50614UQ02, 50615UQ02, 50884UQ04, || 50281UQ12, 50615UQ02, 51177UQ06, 50279UQ12, || 50280UQ12, 50031UQ10, 50007UQ10, 50281UQ12.
  • Product Description
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED WITH SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ABBOTT LABORATORIES || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Safety Alert for HEMOGLOBIN A1C REAGENT KIT
ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
  • Model / Serial
    Reference. 9D31-20 Lot. 45059UN14
  • Manufacturer
    Abbott Laboratories de Colombia S.A.
  • 1 Event
    • Safety Alert for ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
Multichem S Plus (Assayed) Level 2
  • Model / Serial
    Reference: 5P78-11. Lot13811132
  • Product Description
    Determination of analytes related to samples from the human organism
  • Manufacturer
    Abbott Laboratories de Colombia S.A. Brand. Technopath
  • 1 Event
    • Safety Alert for Multichem S Plus (Assayed) Level 2
ICT SERUM CALIBRATOR
  • Model / Serial
  • Product Description
    Quantitative determination of the related analytes in samples from the Human organism.
  • Manufacturer
    Abbott Laboratories Division Diagnostics Usa
  • 1 Event
    • Safety Alert for ICT SERUM CALIBRATOR
ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
  • Model / Serial
  • Product Description
    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
    • Safety Alert for ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
Chemiluminescent immunoanalysis - Anti-HB II
  • Model / Serial
    Reference. 8L4425 Lots: 42072LI00, 42072LI01, 42253LI00, 42253LI01, Reference.8L44-30 Lots 42255LI00, 4225LI01, Reference. 8L44-35 Lot 42256LI00
  • Product Description
    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
    • Safety Alert for Chemiluminescent immunoanalysis - Anti-HB II
ABBOTT REAL TIME HIV 1 - REAGENT KIT
  • Model / Serial
    Lot: 462605
  • Product Description
    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
    • Safety Alert for ABBOTT REAL TIME HIV 1 - REAGENT KIT
REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Model / Serial
  • Product Description
    REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Manufacturer
    ABBOTT MOLECULAR INC. || Imported by: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Safety Alert for REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
Coronary Dilatation Catheter NC Trek
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    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
    • Safety Alert for Coronary Dilatation Catheter NC Trek
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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.