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Vista de la lista Vista de las tarjetas
  • Dispositivo 995
  • Fabricante 138
  • Evento 124969
  • Implante 0
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)
VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medica...
  • Modelo / Serial
    VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)VITROS AFP Reagent PackDevice Identifier: 10758750006489Product Code: 1925551VITROS AFP CalibratorsDevice Identifier: 10758750006540Product Code: 1515154Lot Number: 1470Expiry Date: 13 Dec 2016ARTG Number: 248385
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)
VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).Product Code: 6800598Lot Numbers: 0860, 0870, 0880, 0890, 0908ARTG Number: 251956
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).
VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol ...
  • Modelo / Serial
    VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)Product Code: 8552630Lot Numbers: 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558, 1568ARTG Number: 176641
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)
VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical dev...
  • Modelo / Serial
    VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)GLU SlidesProduct Code: 1707801Current/In-date Generations (GENs): 10, 11, 20 through 31LAC SlidesProduct Codes: 8433880, 8150112Current/In-date GENs: 30, 31TRIG SlidesProduct Codes: 1336544, 8329930Current/In-date GENs: 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32URIC SlidesProduct Code: 1943927Current/In-date GENs: 26, 27, 28, 29, 31ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)
VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro di...
  • Modelo / Serial
    VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD)VITROS Automation Solutions with TCAutomation System (TAC)Product Code: 6844300Software version: 3.6.2 and belowThermo Scientific Centrifuge ModuleProduct Code: 952040ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD)
VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ...
  • Modelo / Serial
    VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD)Intact PTH Reagent PackProduct Code: 6802892Lot Numbers: 0700 (exp.18-10-16), 0710 (exp. 14-11-16), 0748 (exp. 6-2-17), 0758 (exp. 6-3-17)Intact PTH CalibratorsProduct Code: 6802893Lot Numbers: 0728 (exp.12-12-16), 0738 (exp. 2-1-17), 0768 (exp.10-4-17)ARTG number: 176641
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD)
VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Che...
  • Modelo / Serial
    VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).Product Code: 6801896Lot Number: 2576Expiry Date: 02 Sept 2017ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).
VITROS Chemistry Products C-reactive protein (CRP) Slides
  • Modelo / Serial
    VITROS Chemistry Products C-reactive protein (CRP) SlidesProduct Codes: 1926740, 8097990Unique Identification Numbers: 10758750000296, 10758750004355Affected Generations (GENs): 3, 11, 12, 30 through 36This issue may affect expired, current (in date) and future product GENsARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products C-reactive protein (CRP) Slides
VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in ...
  • Modelo / Serial
    VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD). VITROS Chemistry Products PHYT SlidesProduct Code: 8298671 Lot Numbers: all current (in date) lotsCalibration Diskette (Product Code: 8716607) & Assay Data Diskette (ADD) (Product Code: 6801876) versions (DRV) 5909 and belowARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD).
Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).Product Code: 6902319Lot Number: VRC226Expiry: 3 January 2017ARTG Number: 254792
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).
VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5...
  • Modelo / Serial
    VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). An in vitro diagnostic medical device (IVD).VITROS UPRO Slides GENs 14, 15, 16, 17 & 18Product Code: 6800120Expiry Date range: 1 Jan 2017 to 1 May 2018ARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). 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)
VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).Product Code: 6801709Lot Numbers: 31-5407 (Exp. 23 May 2017), 31-5474 (Exp. 4 July 2017) , 31-5506 (Exp. 4 July 2017)ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).
VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)Unique Device Identifier Number: 10758750002061Product Code: 6502156Lot Numbers: 1570 (exp. 22 Mar 2017), 1580 (exp. 13 Apr 2017), 1590 (exp. 27 Apr 2017) and 1620 (exp. 06 Jul 2017)ARTG Number: 245492
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with ...
  • Modelo / Serial
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)Unique Identifier Number: 10758750004690Product Code: 8298671Affects expired, current (in date) and future products GENsARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)
VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)Product Code (Unique Identifier): 8231474 (10758750004577)Lot Number: K4852Expiry: 22 Feb 2018
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)
VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)Product Code: 1072693Lot Numbers: 4492 and aboveExpiry: 13 Aug 2017 and later (as until this issue is resolved, future lots may be affected)ARTG: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).Unique Identifier Number:10758750004690Product Code: 8298671Generation: GEN 16Coating ID: Coating 0165Multiple Lot NumbersExpiry date:15 March 2018 through to 15 June 2018ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products PHYT Slides. 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)Product Code:8379034Affected Generations: GENs: 8, 13, 14, 16, 17, 18Expiry Dates: 01-Nov-2018 through 01-Nov-2019ARTG Number: 232249(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry electrolyte IVDs)
  • 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)
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