International Medical Devices Database

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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)

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 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)

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

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

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)

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)

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

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

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)

Advocate Redi-Code+BMB-BA006A Blood Glucose Test Strips - All Lots

Modelo / Serial
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Diabetic Supply of Suncoast, Inc.
1 Event
- Retiro De Equipo (Recall) de Advocate Redi-Code+BMB-BA006A Blood Glucose Test Strips - All Lots

LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems

Modelo / Serial
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Magellan Diagnostics Inc.
1 Event
- Retiro De Equipo (Recall) de LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems

BD Vacutainer EDTA Lavender, Tan and Pink Top Tubed - BD Vvacutainer Lithium Heparin Green Top Tube

Modelo / Serial
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Becton Dickinson
1 Event
- Retiro De Equipo (Recall) de BD Vacutainer EDTA Lavender, Tan and Pink Top Tubed - BD Vvacutainer Lithium Heparin Green Top Tube

Jaundice Meter JM-103 and JM 105

Modelo / Serial
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Draeger Medical Systems
1 Event
- Retiro De Equipo (Recall) de Jaundice Meter JM-103 and JM 105

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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.