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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dim...
  • Modelo / Serial
    ADVIA Centaur, Dimension Vista & Immulite SystemsAssay: ADVIA Centaur ProgesteroneTest Code: PRGECatalogue/SMN # 10310305, 10315522, 10333111Assay: Dimension Vista LOCI ProgesteroneTest Code: PROGCatalogue: K6464SMN: 10461743Assay: Immulite/Immulite 1000 ProgesteroneTest Code: PRGCatalogue: LKPW1SMN: 10381128Assay: Immulite 2000 ProgesteroneTest Code: PRGCatalogue: L2KPW2, L2KPW6SMNs: 10381181, 10381170All LotsARTG # 175698, 180109, 179720
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)Unique Device Identifier Number: 10758750004812Product Code: 8379034Generation (GEN): 1 through 6, 30 through 40, 44 through 49Expiry Dates: 01 Jan 2017 through 01 Jun 2018ARTG Number: 232249
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).Siemens Material Numbers: 10444834, 10453531, 10453570, 10453571, 10470384All software versions affectedAll serial numbers affectedARTG Number: 174699
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).
VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 an...
  • Modelo / Serial
    VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostics System, software version 3.2.2 and belowProduct Code: 6802783Unique Device ID: 10758750002979VITROS 5600 Integrated System, software version 3.2.2 and belowProduct Code: 6802413Unique Device ID: 10758750002740ARTG Number: 180199
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)
Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)Product affected: Estradiol IIIMaterial Number: 06656021190All lots affectedARTG Number: 174907
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Roche Diagnostics Australia Pty Limited
  • 1 Event
    • Retiro De Equipo (Recall) de Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)
Radiometer ABL90 Flex blood gas analyser. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Radiometer ABL90 Flex blood gas analyser. An in vitro diagnostic medical device (IVD)All Serial Numbers with software version 3.3 MR1 or lowerARTG Number: 228382(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Radiometer Pacific Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Radiometer ABL90 Flex blood gas analyser. An in vitro diagnostic medical device (IVD)
iQ200 Series Urine Microscopy Analysers
  • Modelo / Serial
    iQ200 Series Urine Microscopy AnalysersPart Numbers: 700-3345, 700-3375, 700-3325, 700-3347Model Numbers: 700-3345-iQ200 Select, 700-3375-IQ Elite, 700-3325-iQ200 Sprint, 700-3347-iQ SelectManufactured between Jul 2000 to Jan 2017ARTG Number: 177999
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de iQ200 Series Urine Microscopy Analysers
Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device
  • Modelo / Serial
    Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical deviceARTG Number: 177999
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device
Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD)List Number: 02P75-01, 01G46-01, 09D32-05ARTG Number: 199356
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division
  • 1 Event
    • Retiro De Equipo (Recall) de Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD)
Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 228382
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Radiometer Pacific Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)
Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module
  • Modelo / Serial
    Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 moduleMaterial Number: 04745922001cobas e 602 moduleMaterial Number: 05990378001MODULAR ANALYTICS analyserMaterial Number: 03617505001MODULAR ANALYTICS EVO analyserMaterial Number: 04998642001All software versionsARTG Number: 173887
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Roche Diagnostics Australia Pty Limited
  • 1 Event
    • Retiro De Equipo (Recall) de Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module
COMPLETE SYSTEM FOR DETERMINATION AMPEROMETRICADE GLUCOSE LIFESCAN
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    LifeScan, Johnson & Johnson
  • 1 Event
    • Alerta De Seguridad para COMPLETE SYSTEM FOR DETERMINATION AMPEROMETRICADE GLUCOSE LIFESCAN
COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 1013...
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho Clinical Diagnostics
  • 1 Event
    • Alerta De Seguridad para COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 10132590479 / LOTS: 3151 E 3170
ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213.
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Abbott Laboratórios do Brasil Ltda
  • 1 Event
    • Alerta De Seguridad para ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213.
Anvisa Registry: 80146501315 ///////////////////////////////////////////// //////////////////////...
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    ABBOTT LABORATÓRIOS DO BRASIL LTDA.
  • 1 Event
    • Alerta De Seguridad para Anvisa Registry: 80146501315 ///////////////////////////////////////////// ///////////////////////////////////////////////. Product / Lot / Validity. OPTIUM TIRAS TEST 10UN / 45001A233 / 30.06.2011 /. OPTIUM TIRAS TEST 25UN / 45001A285 / 31.07.2011 /. OPTIUM TIRAS TEST 50UN / 45001A247 / 31.07.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A790 / 30.11.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A852 / 31.12.2011. OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A641 / 31.10.2011 / OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A921 / 31.12.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A665 / 31.10.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A771 / 30.11.2011. 80146501661. OPTIUM XCEED TIRAS POC - 50UN / 45964 / 31.10.2011 /
Registration Anvisa / product / lot and validity. 80146501315. OPTIUM TIRAS TEST 10UN / 45001A233...
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    ABBOTT LABORATÓRIOS DO BRASIL LTDA.
  • 1 Event
    • Alerta De Seguridad para Registration Anvisa / product / lot and validity. 80146501315. OPTIUM TIRAS TEST 10UN / 45001A233 / 30.06.2011 /. OPTIUM TIRAS TEST 25UN / 45001A285 / 31.07.2011 /. OPTIUM TIRAS TEST 50UN / 45001A247 / 31.07.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A790 / 30.11.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A852 / 31.12.2011. OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A641 / 31.10.2011 / OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A921 / 31.12.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A665 / 31.10.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A771 / 30.11.2011. 80146501661. OPTIUM XCEED TIRAS POC - 50UN / 45964 / 31.10.2011 /
ARCHITECT "I" SYSTEM - STAT TROPONIN-I ASSAY
  • Modelo / Serial
    Model Catalog: 2K41-25 (Lot serial: 11455C006); Model Catalog: 2K41-20 (Lot serial: 11455C006); Model Catalog: 2K41-30 (Lot serial: 16250UN07); Model Catalog: 2K41-25 (Lot serial: 16250UN07); Model Catalog: 2K41-20 (Lot serial: 16250UN07); Model Catalog: 2K41-30 (Lot serial: 14343UN06); Model Catalog: 2K41-25 (Lot serial: 14343UN06); Model Catalog: 2K41-20 (Lot serial: 14343UN06); Model Catalog: 2K41-30 (Lot serial: 14350UN06); Model Catalog: 2K41-25 (Lot serial: 14350UN06); Model Catalog: 2K41-20 (Lot serial: 14350UN06); Model Catalog: 2K41-30 (Lot serial: 14339UN06); Model Catalog: 2K41-25 (Lot serial: 14339UN06); Model Catalog: 2K41-20 (Lot serial: 14339UN06); Model Catalog: 2K41-30 (Lot serial: 11370C006); Model Catalog: 2K41-25 (Lot serial: 11370C006); Model Catalog: 2K41-20 (Lot serial: 11370C006); Model Catalog: 2K41-30 (Lot serial: 12987UN06); Model Catalog: 2K41-25 (Lot serial: 12987UN06); Model Catalog: 2K41-20 (Lot serial: 12987UN06); Model Catalog: 2K41-30 (Lot serial: 13122UN06); Model Catalog:
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    ARCHITECT SYSTEM-STAT TROPONIN-I ASSAY
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • 1 Event
    • Retiro De Equipo (Recall) de ARCHITECT "I" SYSTEM - STAT TROPONIN-I ASSAY
PLUM A+ VOLUMETRIC INFUSION PUMP
  • Modelo / Serial
    Model Catalog: (Lot serial: various)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    PLUM A+ AND PLUM A+3
  • Manufacturer
    ABBOTT LABORATORIES HOSPITAL PRODUCTS DIV.
  • 1 Event
    • Retiro De Equipo (Recall) de PLUM A+ VOLUMETRIC INFUSION PUMP
ARCHITECT SYSTEM - FREE T4 ASSAY
  • Modelo / Serial
    Model Catalog: 7G96-01 (Lot serial: 94493M300)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    FREE T4 CALIBRATOR
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • 1 Event
    • Retiro De Equipo (Recall) de ARCHITECT SYSTEM - FREE T4 ASSAY
TRIAGE CARDIO PROFILER
  • Modelo / Serial
    Model Catalog: 97100CP (Lot serial: W49606B); Model Catalog: 97100CPEU (Lot serial: W50739B); Model Catalog: 97100CP (Lot serial: W50739B); Model Catalog: 97100CPEU (Lot serial: W49640B); Model Catalog: 97100CP (Lot serial: W49640B); Model Catalog: 97100CPEU (Lot serial: W49630B); Model Catalog: 97100CP (Lot serial: W49630B); Model Catalog: 97100CPEU (Lot serial: W49606B); Model Catalog: 97100CP (Lot serial: W49611B); Model Catalog: 97100CPEU (Lot serial: W49611B); Model Catalog: 97100CPEU (Lot serial: W50756RB); Model Catalog: 97100CP (Lot serial: W50756RB); Model Catalog: 97000HSEU (Lot serial: W50628B); Model Catalog: 97000HS (Lot serial: W50628B); Model Catalog: 97000HSEU (Lot serial: W50653RB); Model Catalog: 97000HS (Lot serial: W50653RB); Model Catalog: 97000HSEU (Lot serial: W50608B); Model Catalog: 97000HS (Lot serial: W50608B); Model Catalog: 97000HSEU (Lot serial: W49767B); Model Catalog: 97000HS (Lot serial: W49767B); Model Catalog: 97000HSEU (Lot serial: W49758B); Model Catalog: 97000HS (Lot ser
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    Alere Triage CardioProfiler Panel
  • Manufacturer
    ALERE CANADA
  • 1 Event
    • Retiro De Equipo (Recall) de TRIAGE CARDIO PROFILER
BECKMAN COULTER AU2700 IMMUNOCHEM SYS - URIC ACID(NEW FORMULATION)ASSAY
  • Modelo / Serial
    Model Catalog: OSR6298 (Lot serial: ALL LOTS); Model Catalog: OSR6198 (Lot serial: ALL LOTS); Model Catalog: OSR6098 (Lot serial: ALL LOTS); Model Catalog: OSR6616 (Lot serial: ALL LOTS); Model Catalog: OSR6516 (Lot serial: ALL LOTS); Model Catalog: OSR6216 (Lot serial: ALL LOTS); Model Catalog: OSR6116 (Lot serial: ALL LOTS); Model Catalog: OSR6193 (Lot serial: ALL LOTS); Model Catalog: OSR60118 (Lot serial: ALL LOTS); Model Catalog: OSR61118 (Lot serial: ALL LOTS); Model Catalog: OSR66118 (Lot serial: ALL LOTS); Model Catalog: OSR61204 (Lot serial: ALL LOTS); Model Catalog: OSR6130 (Lot serial: ALL LOTS); Model Catalog: OSR6230 (Lot serial: ALL LOTS)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    Uric Acid OSR6x98;Cholesterol OSR6x16;Lactate OSR6x93;Triglyceride OSR6x118;Enzymatic Creatinine OSR6x204;Lipase OSR6x30
  • Manufacturer
    BECKMAN COULTER CANADA L.P.
  • 1 Event
    • Retiro De Equipo (Recall) de BECKMAN COULTER AU2700 IMMUNOCHEM SYS - URIC ACID(NEW FORMULATION)ASSAY
COBAS INTEGRA SYSTEM - VALPORIC ACID
  • Modelo / Serial
    Model Catalog: 04491041190 (Lot serial: PLUSIEURS LOTS)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    COBAS INTEGRA SYSTEM VALPROIC ACID
  • Manufacturer
    ROCHE DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de COBAS INTEGRA SYSTEM - VALPORIC ACID
VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Modelo / Serial
    Model Catalog: 8633893 (Lot serial: C/N 30000755)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    VITROS ECI IMMUNODIAGNOSTIC ANALYZER
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
IMMULITE SYSTEM - ESTRADIOL ASSAY
  • Modelo / Serial
    Model Catalog: LKE21 (Lot serial: ALL)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    IMMULITE/IMMULITE 1000 ESTRADIOL
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED
  • 1 Event
    • Retiro De Equipo (Recall) de IMMULITE SYSTEM - ESTRADIOL ASSAY
BECKMAN COULTER AU600/AU640 ANALYZER- CLASS 2
  • Modelo / Serial
    Model Catalog: AU640E (Lot serial: All serial numbers); Model Catalog: AU600 (Lot serial: All serial numbers); Model Catalog: AU640 (Lot serial: All serial numbers); Model Catalog: AU480 (Lot serial: All serial numbers); Model Catalog: AU680 (Lot serial: All serial numbers); Model Catalog: AU2700 (Lot serial: All Serial Numbers); Model Catalog: AU5400 (Lot serial: All serial numbers); Model Catalog: AU400E (Lot serial: All serial numbers); Model Catalog: AU400 (Lot serial: All serial numbers)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    AU600/AU640/AU640E CLINICAL CHEMISTRY ANALYZERS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.
  • 1 Event
    • Retiro De Equipo (Recall) de BECKMAN COULTER AU600/AU640 ANALYZER- CLASS 2
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Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

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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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