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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
ADVIA 180 System Software V2.01
  • Modelo / Serial
    Product Code: 10639244
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    ADVIA 1800 System Software V2.01. || Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
  • Manufacturer
    Siemens Healthcare Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA 180 System Software V2.01
ADVIA 2400 Chemistry System
  • Modelo / Serial
    All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA 2400 Chemistry System
ADVIA 2400 System Software V4.01
  • Modelo / Serial
    Product Code: 10639265
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
  • Descripción del producto
    ADVIA 2400 System Software V4.01. || Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
  • Manufacturer
    Siemens Healthcare Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA 2400 System Software V4.01
ADVIA Centaur
  • Modelo / Serial
    Product Codes: 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011 and 10361012
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Descripción del producto
    ADVIA Centaur (including refurbished) || Professional use in a laboratory for in vitro diagnostic tests.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur
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
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))
ADVIA Centaur BNA Assay
  • Modelo / Serial
    Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
  • Descripción del producto
    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: || Cat No. 02816138/SMN 10309044 (100 test) || 02816634/SMN 10309045 (500 test)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur BNA Assay
ADVIA Centaur Cleaning Solution Concentrate
  • Modelo / Serial
    Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
  • Descripción del producto
    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) || Catalog Number: 112748 || (Siemens Material Number (SMN): 10310041 || The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Cleaning Solution Concentrate
ADVIA Centaur CP System
  • Modelo / Serial
    All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide
  • Descripción del producto
    ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
  • Manufacturer
    Siemens Healthcare Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur CP System
ADVIA CENTAUR CP SYSTEM - ENHANCED ESTRADIOL (EE2) ASSAY
  • Modelo / Serial
    Model Catalog: 10490889 (Lot serial: ALL); Model Catalog: 10491445 (Lot serial: ALL)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    ADVIA CENTAUR ENHANCED ESTRADIOL
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA CENTAUR CP SYSTEM - ENHANCED ESTRADIOL (EE2) ASSAY
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
ADVIA Centaur¿ Folate (FOL)
  • Modelo / Serial
    ADVIA Centaur¿ Folate; acid, folic, radioimmunoassay; SMN 10310308; 10325366; 10331250   Lot codes: ADVIA Centaur Folate (REF) Lot # 03460256 09302256 81236256 09294257 30152258 ADVIA Centaur Folate (100 Test) Lot # 76793256 85114256 96368256 05299257 99361257 19045258 25443258 40856260 ADVIA Centaur Folate (500 test) Lot # 73249256 76207256 85113256 00245257 00495257 03779257 05298257 99360257 19042258 19043258 19044258 31130258 36171260
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada, Mexico, and Thailand
  • Descripción del producto
    ADVIA Centaur¿ Folate (FOL)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur¿ Folate (FOL)
ADVIA Centaur Immunoassay System
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.
  • Descripción del producto
    ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012 --- For in vitro diagnostic use || This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
  • Manufacturer
    Siemens Healthcare Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Immunoassay System
ADVIA Centaur Intact PTH Calibrator
  • Modelo / Serial
    Kit Lot: 14136A16 04 Mar 2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MD, PA, and CT.
  • Descripción del producto
    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 || For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Intact PTH Calibrator
ADVIA Centaur Intact PTH (iPTH) Assay
  • Modelo / Serial
    500 Test Kits Kit Lot Number Expiry Date 17436138 15 January 2009 17601138 15 January 2009 19464138 15 January 2009 21240138 15 January 2009 23262138 15 January 2009 100 Test Kits Kit Lot Number Expiry Date 17435138 15 January 2009 18338138 15 January 2009 19929138 15 January 2009 20943138 15 January 2009 21835138 15 January 2009
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.
  • Descripción del producto
    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) || Cat. Nos. || 100 Test kit 04385983 (129501) || 500 Test kit 06587575 (129502). || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Intact PTH (iPTH) Assay
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
ADVIA Centaur Systems Insulin Calibrator
  • Modelo / Serial
    Kit Lots Ending: 59, 67, 70, 74
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US OUS: Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Hungary, Italy, Luxembourg, Latvia, Netherlands, Norway, Greece, Croatia, Poland, Portugal, Romania, Sweden, Slovak Republic, Turkey
  • Descripción del producto
    ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems Insulin Calibrator
ADVIA Centaur Systems Insulin ReadyPack
  • Modelo / Serial
    Kit Lots Ending: 169, 170, 173, 174
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US OUS: Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Hungary, Italy, Luxembourg, Latvia, Netherlands, Norway, Greece, Croatia, Poland, Portugal, Romania, Sweden, Slovak Republic, Turkey
  • Descripción del producto
    ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems Insulin ReadyPack
ADVIA Centaur Systems TSH3 Ultra
  • Modelo / Serial
    Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
  • Descripción del producto
    ADVIA Centaur Systems TSH3 Ultra 2500 tests || Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems TSH3 Ultra
ADVIA Centaur Systems TSH3 Ultra Ready Pack
  • Modelo / Serial
    Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 273 18 November 2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
  • Descripción del producto
    ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test || Catalog Number: 06491072; Siemens Material Number: 10282378. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems TSH3 Ultra Ready Pack
ADVIA Centaur Systems VitD 100 test, Ready Pack
  • Modelo / Serial
    Kit lots ending in/Exp Date: 023 07 July 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
  • Descripción del producto
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems VitD 100 test, Ready Pack
ADVIA Centaur Systems VitD 500 test, Ready Pack
  • Modelo / Serial
    Kit lots ending in/Exp Date: 023 07J uly 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
  • Descripción del producto
    ADVIA Centaur Systems VitD 500 test, Ready Pack, || Catalog Number: 10631021. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems VitD 500 test, Ready Pack
ADVIA Centaur Systems VitD Total 100 test, Ready Pack
  • Modelo / Serial
    Kit lots ending in/Exp Date: 050 08 August 2014 051 20 September 2014 052 11 December 2014 053 10 December 2014 054 07 March 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
  • Descripción del producto
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, || For OUS; SMN 10699201. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur Systems VitD Total 100 test, Ready Pack
ADVIA Centaur XP Immunoassay System
  • Modelo / Serial
    Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696 and 10471899.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Descripción del producto
    ADVIA Centaur XP Immunoassay System (including refurbished) || Professional use in a laboratory for in vitro diagnostic tests.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur XP Immunoassay System
ADVIA Centaur XP Immunoassay System
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen, and Zimbabwe.
  • Descripción del producto
    ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, || 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use || This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
  • Manufacturer
    Siemens Healthcare Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de ADVIA Centaur XP Immunoassay System
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