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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A64903  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 680i || The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A64871  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 660i || The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A59102  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 880i || The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A11812  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 800 PRO || The UniCel¿ DxC Synchron¿Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A11816  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 800 || The UniCel¿ DxC Synchron¿Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A27318  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 600i || The UniCel¿ DxC Synchron¿Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A11810  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ 600 PRO || The UniCel¿ DxC Synchron¿Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
Unicel DXC and SYNCHRON LX Clinical Systems
  • Modelo / Serial
    Part Number: A10405  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macao, Mexico, Namibia, Netherlands, Nez Zealand, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel¿ DxC 600 || The UniCel¿ DxC Synchron¿Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
OneTouch Verio IQ
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    OneTouch Verio IQ
  • Manufacturer
    LifeScan
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de OneTouch Verio IQ
FreeStyle Lite Blood Glucose Test Strips
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    FreeStyle Lite Blood Glucose Test Strips
  • Manufacturer
    Abbott Diabetes Care
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de FreeStyle Lite Blood Glucose Test Strips
G4 Platinum and GS Mobile receiver
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Dexcom Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de G4 Platinum and GS Mobile receiver
G4 Platinum and G5 Mobile receiver
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Dexcom
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de G4 Platinum and G5 Mobile receiver
Jaundice Meter, JM-103
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Draeger Medical Systems, Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Jaundice Meter, JM-103
BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Becton Dickinson and Company
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
Jaundice Meter, JM-105
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Draeger Medical Systems, Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Jaundice Meter, JM-105
FreeStyle Lite® Test Strips
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    FreeStyle Lite® Test Strips
  • Manufacturer
    Abbott Diabetes Care
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de FreeStyle Lite® Test Strips
FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems
  • Manufacturer
    Abbott Diabetes Care
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems
G4 PLATINUM and G5 Mobile Receivers
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    G4 PLATINUM and G5 Mobile Receivers. Priority 2 – Warning
  • Manufacturer
    Dexcom, Inc
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de G4 PLATINUM and G5 Mobile Receivers
BD Vacutainer® EDTA & Lithium Heparin blood collection tubes
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    BD Vacutainer® EDTA & Lithium Heparin blood collection tubes - IFU update. Priority 2 – Warning
  • Manufacturer
    Becton, Dickinson & Company
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de BD Vacutainer® EDTA & Lithium Heparin blood collection tubes
Jaundice Meters JM-103, JM-105
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    Jaundice Meters JM-103, JM-105. Priority 2 – Warning
  • Manufacturer
    Draeger Medical Systems Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Jaundice Meters JM-103, JM-105
freestyle mini® and freestyle® blood glucose monitoring system
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Abbott Diabetes Care
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de freestyle mini® and freestyle® blood glucose monitoring system
BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Becton Dickinson and Company
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
Jaundice Meter JM-103 + Jaundice Meter JM-105
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Draeger Medical Systems, Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Jaundice Meter JM-103 + Jaundice Meter JM-105
OneTouch Verio Pro Blood Glucose Meter
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    LifeScan Europe
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de OneTouch Verio Pro Blood Glucose Meter
Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)Catalogue number: DF107 (SMN10444938)Lot number: FA3316ARTG 182779
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division
  • 1 Event
    • Retiro De Equipo (Recall) de Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)
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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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