International Medical Devices Database

VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).

Modelo / Serial
VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).Product codes 6800100 and 1H5419
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Retiro De Equipo (Recall) de VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).

VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quanti...

Modelo / Serial
VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)GEN 38. Coating 0060GEN 39. Coating 0062GEN 40. Coating 0063GEN 41. Coating 0064Expiry date range: 1 April 2013 through 1 February 2014
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Retiro De Equipo (Recall) de VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)

Medtronic Paradigm Insulin Pump

Modelo / Serial
Medtronic Paradigm Insulin PumpModel Numbers: MMT-511, MMT-515, MMT-554, MMT-715, MMT-754, MMT-512, MMT-522, MMT-712, MMT-722ARTG Number: 95763
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Medtronic Australasia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Medtronic Paradigm Insulin Pump

Liquichek ToRCH Plus IgM Control - Positive (An in vitro diagnostic medical device (IVD))

Modelo / Serial
Liquichek ToRCH Plus IgM Control - Positive (An in vitro diagnostic medical device (IVD))Catalogue Numbers: 229 and 229PXLot Number: 18972
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Bio-Rad Laboratories Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Liquichek ToRCH Plus IgM Control - Positive (An in vitro diagnostic medical device (IVD))

Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device...

Modelo / Serial
Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device (IVD)Catalogue number: 10444938Lot number: 2ED072 and 2KD084ARTG: 182779
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device (IVD)

SYNCHRON Systems Lactate (LACT). An in vitro diagnostic medical device (IVD).

Modelo / Serial
SYNCHRON Systems Lactate (LACT). An in vitro diagnostic medical device (IVD).Reference number: A95550Lot number: M210077Expiration date: 2013-10-31
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Beckman Coulter Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de SYNCHRON Systems Lactate (LACT). An in vitro diagnostic medical device (IVD).

D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analy...

Modelo / Serial
D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analysers (An in vitro diagnostic medical device (IVD)
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Radiometer Pacific Pty Ltd
1 Event
- Retiro De Equipo (Recall) de D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analysers (An in vitro diagnostic medical device (IVD)

COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

Modelo / Serial
COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Roche Diagnostics Australia Pty Limited
1 Event
- Retiro De Equipo (Recall) de COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry ...

Modelo / Serial
ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers)Part Numbers: MU3226 and MU7638All model numbers affectedARTG Number: 177999
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Beckman Coulter Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers)

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medic...

Modelo / Serial
Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD) Catalogue Number: K4089Lot Numbers: 12300BB, 12318BB and 13011BBARTG Number: 182779
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)

VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

Modelo / Serial
VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysersCatalogue Number: 10380063Siemens Reference Number: IMS 14-01ARTG Number: 174383
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)

Modelo / Serial
Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent CartridgeDimension Vista CSA:Catalogue Number: K4089Siemens Material Number: 10445139Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BBDimension Vista CSAE:Catalogue Number: K4108Siemens Material Number: 10445142Lot Numbers: 13157BC & 13429BDARTG Number: 182779
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready

Modelo / Serial
ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra ReadyPack. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 02789602 (100 tests) and 02790309 (500 tests)Lot Numbers:Kit Lots ending in 078Expiration: 18 July, 2014Kit Lots ending in 079Expiration: 18 July 2014Kit Lots ending in 082Expiration: 27 September, 2014Kit Lots ending in 083Expiration: 29 November, 2014Kit Lots ending in 084Expiration: 28 December 2014
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready

5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)

Modelo / Serial
5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)List Number: 04J71-20Lot Numbers: 56944001, 57026001, 57059001 and 57673001
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Abbott Australasia Pty Ltd Molecular Division
1 Event
- Retiro De Equipo (Recall) de 5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)

Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD)

Modelo / Serial
Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD)List Number: 1E46-03Lot Numbers: 21399UN13, 67873UN13, 74710UN13, 82008UN13 & 88884UN13ARTG Number: 194054
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD)

ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))

Modelo / Serial
ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))ADVIA Centaur Immunoassay SystemSiemens Material Number: Multiple ADVIA Centaur XP Immunoassay SystemSiemens Material Number: MultipleAll Serial Numbers ARTG number: 174383
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))

IMMULITE/IMMULITE 1000 - Cortisol Assay - An in vitro diagnostic medical device (IVD)

Modelo / Serial
IMMULITE/IMMULITE 1000 - Cortisol Assay - An in vitro diagnostic medical device (IVD)Catalogue number: LKCO1Siemens Material Number: 10381388Lot Numbers: 381, 382 & 383ARTG Number: 179720
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Ltd Diagnostics Division
1 Event
- Retiro De Equipo (Recall) de IMMULITE/IMMULITE 1000 - Cortisol Assay - An in vitro diagnostic medical device (IVD)

HemoCue Glucose 201 Microcuvettes single packed

Modelo / Serial
HemoCue Glucose 201 Microcuvettes single packedArticle Number: 110718Affected Lot Number: 1310798
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
HemoCue Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de HemoCue Glucose 201 Microcuvettes single packed

Radiometer ABL90 Flex analysers running V3.1MR1 or below

Modelo / Serial
Radiometer ABL90Flex analysers running V3.1MR1 or belowARTG number: 228382
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Radiometer Pacific Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Radiometer ABL90 Flex analysers running V3.1MR1 or below

Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnos...

Modelo / Serial
Access 2 Immunoassay Systems Catalogue numbers: 81600N, 386220, A69186, A12900, A56158, A65531UniCel DxC 600i SYNCHRON Access Clinical System Catalogue numbers: A25640, A25638, A25637, A25635, A25656, A25634An in vitro diagnostic device (IVD)ARTG Number: 177999
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Beckman Coulter Australia Pty Ltd
1 Event
- Retiro De Equipo (Recall) de Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnostic device (IVD)

RAPIDPoint 500 Blood Gas Analyzer

Modelo / Serial
RAPIDPoint 500 Blood Gas AnalyzerSiemens Material Numbers (SMN): 10492730, 10696855, 10696857, 10697306ARTG Number: 175890An in vitro diagnostic medical device (IVD)
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Healthcare Pty Ltd
1 Event
- Retiro De Equipo (Recall) de RAPIDPoint 500 Blood Gas Analyzer

VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS System...

Modelo / Serial
VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).Product code: 8568040Lot Number: 0954Expiry Date: 31 May 2016Unique Device Identifier Number: 10758750005031ARTG number: 245278
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Retiro De Equipo (Recall) de VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).

ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

Modelo / Serial
ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol AssaysADVIA Centaur Enhanced EstradiolCatalogue # and SMN: 10490889, 10491445, 10697757Dimension Vista LOCI EstradiolCat # K6463SMN: 10489099IMMULITE/ IMMULITE 1000 EstradiolCat #: LKE21, LKE21(D)SMN: 10381132, 10702832IMMULITE 2000 EstradiolCat #: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)SMN:10381178, 10702833, 10381177, 10702834All lots affectedARTG # 175698, 180109 and 179720
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Siemens Healthcare Pty Ltd
1 Event
- Retiro De Equipo (Recall) de ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD)

Modelo / Serial
ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD)List Number: 7K72All lot numbers affectedARTG Number: 180112
Clasificación del producto
Clinical Chemistry and Clinical Toxicology Devices
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Retiro De Equipo (Recall) de ARCHITECT Estradiol Reagent. 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)

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