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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Device Recall Siemens RAPIDPoint 500 system
  • Modelo / Serial
    Units shipped between the dates Oct 2011 - June 2015 and within the serial range of 30003-37040 not inclusive.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany,Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands. New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, U.A.E., United Kingdom and Vietnam.
  • Descripción del producto
    RAPIDPoint 500 Blood Gas Analyzer, || Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 || This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary || whole blood samples.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens RAPIDPoint 500 system
Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent
  • Modelo / Serial
    Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
  • Descripción del producto
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. || Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent
Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent
  • Modelo / Serial
    Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
  • Descripción del producto
    Pointe Scientific autoHDL Reagent H7545 || H7545-R1 in a bulk cube container or HDPE plastic bottle || H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 || 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 || HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 || Kits: HDPE plastic bottle, PP plastic caps. || Bulk: PE plastic cube containers, PP plastic caps. || Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
  • Manufacturer
    Pointe Scientific, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent
Device Recall Pointe Scientific Creatinine Reagent
  • Modelo / Serial
    C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
  • Descripción del producto
    Pointe Scientific Creatinine Reagent || Catalog number C7539-150 || in vitro diagnostic || C7539-150 kit includes one R1 and one R2 bottle. || R1: HDPE plastic bottle. 120 ml fill. || R2: HDPE plastic bottle. 90 ml fill.
  • Manufacturer
    Pointe Scientific, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pointe Scientific Creatinine Reagent
Device Recall MedTest DX Control Reconstitution Fluid
  • Modelo / Serial
    Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    MedTest DX Control Reconstitution Fluid || Kit configuration: 20 x 5 ml. || Bottle: 5 ml amber glass || Cap: 18 mm white seal plug seal rubber || HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
  • Manufacturer
    MedtestDx, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MedTest DX Control Reconstitution Fluid
Device Recall Specimen Gate Screenig Center
  • Modelo / Serial
    Software Version 1.6
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US distribution to FL, GA, and NV; and Canada
  • Descripción del producto
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • Manufacturer
    Perkin Elmer Life Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Specimen Gate Screenig Center
Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
  • Modelo / Serial
    Serial Numbers: 2517102517 through 2519000012.  Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates
  • Descripción del producto
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) || Part Number: 10491449 || Product Usage: || The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
  • Modelo / Serial
    Serial Numbers: 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Canada, Albania, Austria, Australia, Bosnia Herzeg., Bangladesh, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Denmark, Estonia, Spain, Finland, France, Great Britain, Georgia, Greece, Croatia, Hungary, Ireland, India, Italy, Lithuania, Luxembourg, Latvia, Macedonia, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Paraguay, Romania, Sweden, Singapore, Slovenia, Slovakia, Turkey, Taiwan, South Africa, Unit.Arab Emirates
  • Descripción del producto
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests || Part Number: 10844813 || Product Usage: || The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 3 Events
    • Retiro De Equipo (Recall) de Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
    • Retiro De Equipo (Recall) de Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
    • Retiro De Equipo (Recall) de Device Recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate
Device Recall Access free T3 Reagent kit
  • Modelo / Serial
    Lot: 431433
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
  • Descripción del producto
    Access Free T3 Reagent Kit, P/N A13422 || The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Access free T3 Reagent kit
Device Recall Alere Cholestech LDX Multianalyte Controls
  • Modelo / Serial
    Lot C3091 and Lot C3091A
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. || Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
  • Manufacturer
    Alere San Diego, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Alere Cholestech LDX Multianalyte Controls
Device Recall ADVIA Chemistry XPT
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.
  • Descripción del producto
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. || An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ADVIA Chemistry XPT
Device Recall Acute Care CTNI TestPak
  • Modelo / Serial
    Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma || Catalog Number: CCTNI || SMN: 10445071
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care CTNI TestPak
Device Recall Acute Care pBNP TestPak
  • Modelo / Serial
    Lot Numbers: 215166002, 215194002, 215222002, 215271002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. || Catalog Number: CPBNPM || SMN: 10445086
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care pBNP TestPak
Device Recall Acute Care CKMB TestPak
  • Modelo / Serial
    Lot Numbers: 245138002, 245152002, 245215002, 245262002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma || Catalog Number: CCKMB || SMN:10445068
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care CKMB TestPak
Device Recall Acute Care BHCG TestPak
  • Modelo / Serial
    Lot Numbers: 445146002, 445201002, 445243002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method || Catalog Number: CBHCG || SMN:10445060
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care BHCG TestPak
Device Recall Acute Care BHCG CalPak
  • Modelo / Serial
    Lot Numbers: 625229002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method || Catalog Number: CBHCG-C || SMN:10445061
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care BHCG CalPak
Device Recall Acute Care CKMB DilPak
  • Modelo / Serial
    Lot Numbers: 845173002
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
  • Descripción del producto
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak || Catalog Number: CCKMB-D || SMN: 10445070
  • Manufacturer
    Siemens Healthcare Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acute Care CKMB DilPak
Device Recall VITROS 3600 Chemistry System
  • Modelo / Serial
    Software Version 3.2 and below; Serial Numbers J36000012 - 36000879
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Descripción del producto
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 3600 Chemistry System
Device Recall VITROS 5600 Chemistry System
  • Modelo / Serial
    Software Version 3.2 and below; Serial Numbers J56000024 - J56002309
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Descripción del producto
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 5600 Chemistry System
Device Recall VITROS 4600 Chemistry System
  • Modelo / Serial
    Software Version 3.2 and below; Serial Numbers J46001001 -J4600636
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Descripción del producto
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. || Product Usage: || The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 4600 Chemistry System
Device Recall VITROS 5,1 FS Chemistry System
  • Modelo / Serial
    Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers 34000133, 34000193, 34000197, 34000212,  34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451,  34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,  34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389,  34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572,  34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840,  34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319,  34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530,  34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576,  34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672,  34000744, 34000745, 34000755, 34000759, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,  34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,  34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,  34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,  34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,  34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,  34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,  34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,  34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551,  34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594,  34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693,  34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798,  34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859,  34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916,  34001923, 34001995.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Descripción del producto
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. || Product Usage: || The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS 5,1 FS Chemistry System
Device Recall MYLA
  • Modelo / Serial
    REF # 414518, Serial number/Software version V3.2 CLI
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
  • Descripción del producto
    MYLA CLINIC PATCH 3.2.0 CD || Product Usage: || MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MYLA
Device Recall MYLA
  • Modelo / Serial
    REF # 415358, Serial number/Software version V3.2 CLI
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
  • Descripción del producto
    MYLA MASTER DVD 3.2 CLI DL380 || Product Usage: || MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MYLA
Device Recall MYLA
  • Modelo / Serial
    REF # 416192, Serial number/Software version V3.3 CLI
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
  • Descripción del producto
    MYLA CLINIC PATCH 3.3.0 CD || Product Usage: || MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MYLA
Device Recall MYLA
  • Modelo / Serial
    REF # 416546, Serial number/Software version V4.0 CLI
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
  • Descripción del producto
    MYLA MASTER DVD V4.0 CLI || Product Usage: || MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MYLA
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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.

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