International Medical Devices Database

Fuente de la data

País

Clasificación del dispositivo

Empresa matriz

Architect Toxo IgM Assay

Modelo / Serial
Architect Toxo IgM AssayList Number: 6C20-25Lot Numbers: 64245LI00 (Exp.: 12/04/2017), 66063LI00 (Exp.: 13/05/2017), 67003LI00 (Exp.: 12/05/2017), 68443LI00 (Exp.: 19/07/2017)ARTG Number: 188821
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de Architect Toxo IgM Assay

Architect Active-B12 Reagent Kit. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Architect Active-B12 Reagent Kit. An in vitro diagnostic medical device (IVD).List Numbers: 3P24-25, 3P24-35Lot Numbers: 10533UP00, 15034UP00Expiry: 29 May 2017ARTG Number: 188927
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de Architect Active-B12 Reagent Kit. An in vitro diagnostic medical device (IVD)

StarClose SE Vascular Closure System (VCS), International Green Sheath

Modelo / Serial
StarClose SE Vascular Closure System (VCS), International Green SheathPart Number: 14679-02Multiple Lot NumbersARTG Number: 240055
Manufacturer
Abbott Vascular Division of Abbott Australasia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de StarClose SE Vascular Closure System (VCS), International Green Sheath

i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridg...

Modelo / Serial
i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).i-STAT1 Analyser – software version JAMS142E i-STAT Celite ACT CartridgesList Number: 03P86-25i-STAT Kaolin ACT CartridgesList Number: 03P87-25ARTG Numbers: 203350, 213851
Manufacturer
Abbott Australasia Pty Ltd Point-of-Care Division
1 Event
- Retiro De Equipo (Recall) de i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).i-STAT1 Analyser – software version JAMS142E i-STAT Celite ACT Cartridges

Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)List Number: 8K26-20Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000 and 00916L000List Number: 8K26-25Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000ARTG Number: 196075
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)

ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 ...

Modelo / Serial
ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)Multiple Lot Numbers (see attached)ARTG Number: 180112
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)Multiple Lot Numbers (see attached)ARTG Number: 180112

MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)

Modelo / Serial
MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)List Number: 8L24-31Lot Numbers: 60335Y600 and 60382Y600List Number: 8L24-41Lot Number: 60334Y600Expiry Date: 28 Feb 2018ARTG Number: 203299
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)

HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3

Modelo / Serial
HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3Serial Number: MLP-002965Supplied through the Special Access Scheme
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3

Alere HIV Combo. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Alere HIV Combo. An in vitro diagnostic medical device (IVD)Catalogue Number: 7D2846Lot Number: 80671K100CPack Size: 20 TestsCatalogue Number: 7D2847Lot Number: 78169K100BPack Size: 100 TestsARTG Number: 276049
Manufacturer
Inverness Medical Innovations Australia Pty Ltd T/A Alere
1 Event
- Retiro De Equipo (Recall) de Alere HIV Combo. An in vitro diagnostic medical device (IVD)

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)List Number: 02G31-010Lot Number: 475025ARTG Number: 217841
Manufacturer
Abbott Australasia Pty Ltd Molecular Division
1 Event
- Retiro De Equipo (Recall) de Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra de...

Modelo / Serial
Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices)Manufactured between January 2010 and May 2015Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MPMultiple ModelsMultiple ARTG Numbers
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices) Manufactured between January 2010 and May 2015 Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MP

NM Implantable Pulse Generator within the Infinity and Proclaim device families

Modelo / Serial
NM Implantable Pulse Generator within the Infinity and Proclaim device familiesRecall for product correctionARTG Numbers: 277755, 277756 Hazard AlertImplantable Pulse Generator ARTG Numbers: 279015, 279016, 282999, 283000, 289235, 278846, 278847, 278849 and 278850
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de NM Implantable Pulse Generator within the Infinity and Proclaim device families

Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices

Modelo / Serial
Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devicesModels: PM1210, PM1224, PM1240, PM1272, PM2212, PM2224, PM2240, PM2272, PM3212, PM3222, PM3242 and PM3262ARTG Numbers: 163890, 185763, 216284, 267512, 163892, 185764, 216285, 267513, 163894, 216290, 216291 and 231759
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Accent / Anthem, Accent MRI / Accent ST, Assurity / Allure and Assurity MRI devices

i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW ...

Modelo / Serial
i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. An in vitro diagnostic medical device (IVD) ARTG Number: 203349 (Abbott Australasia Pty Ltd (Point-of-Care Division) - Clinical chemistry hormone IVDs)
Manufacturer
Abbott Australasia Pty Ltd Point-of-Care Division
1 Event
- Retiro De Equipo (Recall) de i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. An in vitro diagnostic medical device (IVD)

ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)

Modelo / Serial
ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)List Number: 8K27-20 Lot Numbers: 01316K000, 01217A000, 02217D000, 04117H000List Number: 8K27-25Lot Numbers: 01216K000, 01117A000, 02417D000, 00517F000ARTG Number: 196075
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)

CELL-DYN Emerald 22 Analyser with software version v3.0.0. An in vitro diagnostic medical device ...

Modelo / Serial
CELL-DYN Emerald 22 Analyser with software version v3.0.0. An in vitro diagnostic medical device (IVD)List Number: 09H59-01Serial Number: below 000700ARTG Number: 199356
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de CELL-DYN Emerald 22 Analyser with software version v3.0.0. An in vitro diagnostic medical device (IVD)

Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

Modelo / Serial
Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.List Number: 4P52-21Multiple Affected Lot NumbersARTG: 185778
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

Alere Afinion ACR Control. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Alere Afinion ACR Control. An in vitro diagnostic medical device (IVD)Catalogue Number: Af1116046Lot Numbers: 10193874, 10195060ARTG: 204476(Inverness Medical Innovations Australia T/A Alere - Clinical chemistry substrate IVDs)
Manufacturer
Inverness Medical Innovations Australia Pty Ltd T/A Alere
1 Event
- Retiro De Equipo (Recall) de Alere Afinion ACR Control. An in vitro diagnostic medical device (IVD)

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Prom...

Modelo / Serial
Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D DevicesBattery performance update applies to devices manufactured prior to 23 May 2015Multiple ModelsMultiple ARTG Numbers
Manufacturer
Abbott Medical Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D Devices

Implantable Cardioverter Defibrillator

Modelo / Serial
Manufacturer
St. Jude Medical
1 Event
- Retiro De Equipo (Recall) de Implantable Cardioverter Defibrillator

Left ventricular cardiac resynchronization therapy (CRT) leads. Bipolar QuickSite and QuickFlex l...

Modelo / Serial
Manufacturer
St. Jude Medical Inc
1 Event
- Retiro De Equipo (Recall) de Left ventricular cardiac resynchronization therapy (CRT) leads. Bipolar QuickSite and QuickFlex lead models: 1056T, 1058T, 1156T and 1158T.

Implants, active, stimulators, neuro implantation accessory. Eon mini charger – 3719, 3721.

Modelo / Serial
Manufacturer
St. Jude Medical Inc.
1 Event
- Retiro De Equipo (Recall) de Implants, active, stimulators, neuro implantation accessory. Eon mini charger – 3719, 3721.

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

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.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)