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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi
  • Modelo / Serial
    Water Feed Kit - Product Code/Catalog #'s 10288216 and 10389714
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Water Feed Kit, Catalog#10288216,#10389714. || The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
  • Manufacturer
    Siemens Medical Solutions Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi
Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi
  • Modelo / Serial
    Liquid Waste Bottle Kit - Product Code/Catalog #10386287
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Liquid Waste Bottle Kit, Catalog#10386287. || The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
  • Manufacturer
    Siemens Medical Solutions Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi
Device Recall Cobas Homocysteine Enzymatic Assay
  • Modelo / Serial
    05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA  Lot number 69781101
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.
  • Descripción del producto
    Homocysteine test system - Homocysteine Reagent. || 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA || Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cobas Homocysteine Enzymatic Assay
Device Recall RapidLab 1260
  • Modelo / Serial
    Siemens Material Number (SMN): 10321846, 10491394, 10339910
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam.
  • Descripción del producto
    The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole || blood samples.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RapidLab 1260
Device Recall RapidLab 1265
  • Modelo / Serial
    Siemens Material Number (SMN): 10321852, 10470366, 10491395, 10335524
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam.
  • Descripción del producto
    The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole || blood samples.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RapidLab 1265
Device Recall enGen Laboratory Automation System
  • Modelo / Serial
    Serial Numbers: J89134, JIM341226, 341516, JIM342964, JIM340432, JIM340814, IM341243, JIM336912, J271265, J271369, J271372, J271267, J85208, JIM342217, J7023890, J7023841, J7025007, J7024894, J7023648,  J7021530, J57662, J8006290, J75685, J30370, J3055510, J3055507, JIM341820, JIM341679, JIM341174, JIM340667, JIM-341592, JIM336957,  JIM341477, JIM336855, JIM334236, JIM341415, JIM341392, JIM340934,  JIM336167, JIM342249, JIM341750, JIM341426, JIM334527, JIM341021, JIM340658.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
  • Descripción del producto
    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). || COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall enGen Laboratory Automation System
Device Recall VITROS Immunodiagnostic Products Signal Reagent
  • Modelo / Serial
    Lot 3082, expiry date 7/27/2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products Signal Reagent
Device Recall Boehringer Mannheim Cholesterol Assay
  • Modelo / Serial
    Catalog Numbers: 11491458216; 11875540216; 11875523216.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Cholesterol CHOD-PAP. || In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Boehringer Mannheim Cholesterol Assay
Device Recall Total Cholesterol Assay
  • Modelo / Serial
    Catalog Numbers: 04718917190; 03039773190; 05168538190; 03039773190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Cholesterol Gen.2. || The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Total Cholesterol Assay
Device Recall Creatinine Plus
  • Modelo / Serial
    Catalog Numbers: 11775685216; 11875566216; 11875582216.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Creatinine Plus. || Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Creatinine Plus
Device Recall Creatinine reagent
  • Modelo / Serial
    Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Creatinine Plus ver. 2. || Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Creatinine reagent
Device Recall HDLCholesterol, no pretreatment
  • Modelo / Serial
    Catalog Numbers: 05401470190; 03263991190; 05168589190; 03263991190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    HDL-Cholesterol gen.3. || For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HDLCholesterol, no pretreatment
Device Recall HDLCholesterol,
  • Modelo / Serial
    Catalog Numbers: 05401488190; 0439980319; 05168805190; 04399803190, 04878205160.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    HDL-Cholesterol plus gen.3.; and Small Supersized || Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HDLCholesterol,
Device Recall Lactate Dehydrogenase IFCC
  • Modelo / Serial
    Catalog Numbers: 11822837190; 05401666190; 03183700190; 05171881190; 03183700190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Lactate. || Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lactate Dehydrogenase IFCC
Device Recall LDLCholesterol plus 2nd Generation
  • Modelo / Serial
    Catalog numbers 04714423190; 04711220190; 05230438190; 05230446190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    LDL-Cholesterol gen.2. || The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LDLCholesterol plus 2nd Generation
Device Recall Boehringer Mannheim Direct LDLCholesterol
  • Modelo / Serial
    Catalog Numbers 05401682190; 03038866322; 05171369190; 03038866322.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    LDL-Cholesterol plus gen.2. || The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Boehringer Mannheim Direct LDLCholesterol
Device Recall Triglycerides
  • Modelo / Serial
    Catalog Numbers: 04657594190; 20767107322; 05171407190; 20767107322; 11730711216; 11876023216; 11876040216; 11488872216.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Triglycerides GPO. || In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Triglycerides
Device Recall Triglycerides/ Glycerol Blanked
  • Modelo / Serial
    Catalog Numbers:11877771216; 11877780190; 11877798190; 05976006190.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Triglycerides/Glycerol Blanked. || In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Triglycerides/ Glycerol Blanked
Device Recall Uric Acid plus ver.2
  • Modelo / Serial
    Catalog Numbers:04657608190; 03183807190; 05171857190; 03183807190; 11875426216; 11929429216; 11929437216.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including PR.
  • Descripción del producto
    Uric Acid plus ver.2 || In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Uric Acid plus ver.2
Device Recall Architect Alkaline Wash
  • Modelo / Serial
    Lot number 49059UN14, Expiration data 04-MAR-2016.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia, Austria, Croatia, Denmark, France, India, Isreal, Bermuda, Curacao, Cayman Islands, Jamaica, Canada, Bangladesh, Cyprus, Estonia, Greece, Indonesia, Italy, Kazakhstan, Latvia, Macedonia, Norway, Portugal, Russia, Slovakia, Spain, Taiwan, UAE, Kenya, Lithuania, Malaysia, Philippines, Qatar, Saudi Arabia, Slovenia, Sweden, Tunisia, United Kingdom, Kuwait, Luxembourg, Netherlands, Poland, Romania, Singapore, South Africa, Switzerland, Turkey, and Vietnam.
  • Descripción del producto
    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Architect Alkaline Wash
Device Recall ICT Serum Calibrator
  • Modelo / Serial
    Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Afghanistan, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Curacao, North Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mauritania, Mauritius, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Calicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    ICT Serum Calibrator REF 146-03. || For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ICT Serum Calibrator
Device Recall Dimension Vista Intelligent Lab System
  • Modelo / Serial
    Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,
  • Descripción del producto
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dimension Vista Intelligent Lab System
Device Recall ADVIA Centaur TnIUltra
  • Modelo / Serial
    ***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.****  SMN 10317708 - 100 tests 43796099 May 25, 2015 43818088 May 25, 2015 44793088 May 25, 2015 45687089 June 22, 2015 46527089 June 22, 2015 48096089 June 22, 2015 49216090 August3, 2015 50779090 August3, 2015 52113091 September 14, 2015 53091093 October 19, 2015 54684093 October 19, 2015  SMN 10317709 -500 tests 43797088 May25, 2015 43819088 May25,2015 44098088 May25, 2015 44623088 May 25, 2015 45688089 June 22, 2015 46661089 June 22, 2015 48301090 August3, 2015 49869090 August 3, 2015 50884091 September 14, 2015 51471091 September 14, 2015 51798091 September 14, 2015 53092093 October 19,2015 53231093 October 19,2015 54742094 December 6, 2015
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, and Puerto Rico; and the countries of Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, AR, AU, BD, BR, CA, CL, CN , CO, CR, DO, EC, HK, ID, IE, IL, IN, JP, KR, LK, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN, and ZA.
  • Descripción del producto
    ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests || Product Usage: || For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ADVIA Centaur TnIUltra
Device Recall Infinite F500
  • Modelo / Serial
    Material Number 30019337.  Serial numbers 1212004416 1009002605 612000003 811002510 712004158 906000965 902005109 912003472 1103002583 1411007090 704000003 702000001 708000500 1003004146 1109000103 1412005124 805001219 911005026 708005532 705007195 810000248 1010001663 712004152 708005533 1412005709 1103003780 706004455 608000002 908000185 1009002604 1308001035 804005914 1311007600 804000984 705009034 1309003195 801008055 706007961 901006341
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • Descripción del producto
    Infinite F500, in vitro diagnostic. || Product Usage: || The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Infinite F500
Device Recall Infinite M1000 PRO
  • Modelo / Serial
    Material Number 30063849.  Serial numbers 1304002505 1211001152 1404000702 1411000822 1401004105 1205001934 1308000225 1309006882 1208001184 1204007588 1310005809 1402004302 1211001148 1305006435 1201003163 1404003953 1406001800 1403005820 1402003587 1311007574 1312002863 1406000407 1406004487 1408007771 1310007970 1201003165 1110002126 1203007860 1309000153 1408007772 1502004994 1410008825 1407000743 1406004488 1201007987 1206005852 1406008272 1410008826 1412004769 1404006185 1212002553 1403008861 1309000008 1211004372 1403000810 1208009323 1211001150 1201003164 1204006296 1407000079 1203002067 1206003111 1304004516 1309000007 1302004940 1309000154 1403000809 1212005340 1309000155 1410000939 1310003905 1409008197 1202003111 1303004426 1112005380 1303003793 1403005819 1407000077 1301009861 1503001027 1304008256 1303003794 1304002504 1309008394 1309008392 1208001186 1110002128 1503001025 1312005136 1310003908 1402005998 1309000157 1403008862 1406001502 1406008274 1406008275 1110002125 1207004756 1303003789 1205004103 1310000091 1406005776 1410011653 1211011467 1308001821 1501009602 1501001058 1307003628 1210001739 1305002229 1406006675 1211004368 1209006283 1407003406 1311001092 1406008273 1408001415 1209006284 1204000890 1211004370 1401006398 1402004300 1309005472 1310009816 1109005812 1312002864 1406006678 1301003417 1407003173 1211004364 1401000518 1401000539 1209001065 1208003232 1307001804 1403005818 1311007569 1208003233 1211004369 1409008196 1203005897 1307006629 1212002550 1403003962 1310003902 1206003110 1307001806 1202008407 1205002706 1209000238
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • Descripción del producto
    Infinite M1000 PRO in vitro diagnostic. || Product Usage: || The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Infinite M1000 PRO
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