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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5
  • Modelo / Serial
    MT20649-1, MT20649-2, MT22719- 1 and MT22719-2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    It is a glucose monitoring device designed to identify trends and monitor patterns in people of two or more years with diabetes. It is designed to be used by patients in their own home and in health centers. It is an additional device that complements, but replaces, the information obtained from standard glucose monitoring devices to be used at home. It helps to detect episodes of hyperglycemia and hypoglycaemia, allowing to adjust the treatments of acute and chronic cases.
  • Manufacturer
    Dexcom, Inc
  • 1 Event
    • Alerta De Seguridad para continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5
Leadcare blood lead test kit/Leadcare II blood lead test kit
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    PRODUCT USED IN THE LEAD DETECTION PROCESS IN ORIGIN HUMAN SERUM.
  • Manufacturer
    ESA BIOSCIENCES INC || Imported by: ANNAR DIAGNOSTICA || IMPORT S.A S
  • 1 Event
    • Alerta De Seguridad para Leadcare blood lead test kit/Leadcare II blood lead test kit
strips to measure glucose (glucose Nova Max)
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    Determine the different analytes in samples from the human body
  • Manufacturer
    Nova Biomedical
  • 1 Event
    • Alerta De Seguridad para strips to measure glucose (glucose Nova Max)
SPOTCHEM II PANEL-1 / SPOTCHEM II Glucose Reagent Test Strip
  • Modelo / Serial
    Lots: PN5C26 and EA4M78
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    ARKRAY FACTORY/BIOSYSTEMS S.A.
  • 1 Event
    • Alerta De Seguridad para SPOTCHEM II PANEL-1 / SPOTCHEM II Glucose Reagent Test Strip
Jaundice Meter
  • Modelo / Serial
    JM-105, JM-103
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    Used for the measurement of transcutaneous bilirubin (BTC) for the diagnosis of jaundice.
  • Manufacturer
    Draeger Medical Systems, Inc. || Konica Minolta Inc
  • 1 Event
    • Alerta De Seguridad para Jaundice Meter
Onetouch®pro - glycaemic self-management system intended for home and ambulatory use
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    LifeScanEurope - Division of Cilag GmbH
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Onetouch®pro - glycaemic self-management system intended for home and ambulatory use
Draeger Jaundice Meter JM 103
  • Modelo / Serial
    Model: models JM103 and JM105, Affected:
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Draeger Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Draeger Jaundice Meter JM 103
dexcom g4 platinum receiver
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    md
  • Manufacturer
    DEXCOM
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de dexcom g4 platinum receiver
leadcare / leadcareii / leadcare ultra / leadcare plus
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    ivd
  • Manufacturer
    ICHOR TECHNOLOGIES LTD
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de leadcare / leadcareii / leadcare ultra / leadcare plus
bd vacutainer edta & bd vacutainer lithium heparin tubes
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    ivd
  • Manufacturer
    BECTON DICKINSON AND COMPANY
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de bd vacutainer edta & bd vacutainer lithium heparin tubes
OneTouch Verio IQ Blood Glucose Meters
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    LifeScan
  • 1 Event
    • Retiro De Equipo (Recall) de OneTouch Verio IQ Blood Glucose Meters
VITROS TROPONINE I
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS TROPONINE I
Accu-Chek Performa Test Strips for Blood Glucose Meters
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Accu-Chek Performa Test Strips for Blood Glucose Meters
Device Recall SoftPath
  • Modelo / Serial
    Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution US Nationwide and CANADA.
  • Descripción del producto
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath
Device Recall UniStrip1
  • Modelo / Serial
    U14030713, 814031313, U140312323, and U14031413.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of FL and OH.
  • Descripción del producto
    UniStrip1, Blood Glucose Test Strips, 50 count box. || The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
  • Manufacturer
    Unistrip Technologies LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall UniStrip1
Device Recall VITROS 3600 Immunodiagnostic System
  • Modelo / Serial
    Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. || For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 3600 Immunodiagnostic System
Device Recall VITROS 4600 Chemistry System
  • Modelo / Serial
    Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. || The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 4600 Chemistry System
Device Recall VITROS 5600 Integrated System
  • Modelo / Serial
    Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 5600 Integrated System
Device Recall Dimension Vista Myoglobin Calibrator
  • Modelo / Serial
    Lot 4FD085, exp. 12-01-2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Descripción del producto
    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 || Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dimension Vista Myoglobin Calibrator
Device Recall RTH8 Rotor
  • Modelo / Serial
    Serial No. 3100 through 7012
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.
  • Descripción del producto
    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. || The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
  • Manufacturer
    Iris Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RTH8 Rotor
Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test
  • Modelo / Serial
    PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
  • Descripción del producto
    DrugCheck Ketamine Dip Test || 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. || This assay provides only a preliminary analytical test result.
  • Manufacturer
    Express Diagnostics Int'l., Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test
Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6
  • Modelo / Serial
    Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution.
  • Descripción del producto
    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6
Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1
  • Modelo / Serial
    4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
  • Descripción del producto
    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1
Device Recall Beckman Coulter, Lipase Assay
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
  • Descripción del producto
    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Lipase Assay
Device Recall Beckman Coulter, Uric Acid Assay
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe
  • Descripción del producto
    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Uric Acid Assay
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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