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  • Dispositivo 1004
  • Fabricante 31827
  • Evento 1040
  • Implante 0
BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0
  • Modelo / Serial
    version 4.0 software
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA || Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
  • Manufacturer
    Bio-Rad Laboratories Inc
  • 1 Event
    • Retiro De Equipo (Recall) de BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0
VP 2000 Processor
  • Modelo / Serial
    all units
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Columbia, Czech Republic, Egypt, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Malaysia, Norway, Russia, Saudi Arabia, Singapore, Switzerland and the United Kingdom.
  • Descripción del producto
    VP 2000 Processor; an automated tissue stainer || 100 volt - part 30-144100 or list 2J11-60; || 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; || 230 volt - part 30-144102 or list 2J11-04, and part 30-102833 processor only. || Designed to automate and standardize slide specimen processing including deparafinization, FISH pretreatment and routine slide staining for the laboratory. The unit is preprogrammed to perform slide pretreatment protocols for FISH assays and can be programmed to perform routine histology/cytology slide staining or routine slide washing according to user requirements.
  • Manufacturer
    Abbott Molecular
  • 1 Event
    • Retiro De Equipo (Recall) de VP 2000 Processor
SigmaAldrich Histopaque1077
  • Modelo / Serial
    Lot #038K6170, Exp. 2011-04
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.
  • Descripción del producto
    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. || This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.
  • Manufacturer
    Sigma-Aldrich Mfg LLC
  • 1 Event
    • Retiro De Equipo (Recall) de SigmaAldrich Histopaque1077
PATHWAY HER2 (4B5)
  • Modelo / Serial
    Lot number: 680957
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
  • Descripción del producto
    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY || (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
  • Manufacturer
    Ventana Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de PATHWAY HER2 (4B5)
Variant II Turbo Hemoglobin A1C Program
  • Modelo / Serial
    Lot No. 70291520.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Hong Kong, and New Zealand.
  • Descripción del producto
    Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. || Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
  • Manufacturer
    Bio-Rad Laboratories Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Variant II Turbo Hemoglobin A1C Program
in2it (I) and (II) Test Cartridges
  • Modelo / Serial
    Product code LCP,expiration dates between 2011-07-12 and 2011-07-26. Kit lot numbers (I):072T97, 072T98, 072T100, (II): 074P75, 074P73, Device lot numbers 131Q203 38864, 131Q204 39008, 131Q206 39088
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.
  • Descripción del producto
    in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. || The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.
  • Manufacturer
    Bio-Rad Laboratories Inc
  • 1 Event
    • Retiro De Equipo (Recall) de in2it (I) and (II) Test Cartridges
BioRad D10 Hemoglobing Testing System
  • Modelo / Serial
    Lot 20001814; Exp. February 28,2012
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.
  • Descripción del producto
    Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; || Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA || System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.
  • Manufacturer
    Bio-Rad Laboratories, Inc., Hercules, CA
  • 1 Event
    • Retiro De Equipo (Recall) de BioRad D10 Hemoglobing Testing System
iSTAT ACT Celite Cartridges
  • Modelo / Serial
    List numbers: 07G01-01, 07G01-02,. 600-9006-25; Lot numbers: S10127B, S10136A, S10150A, S10151, S10155.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    i-STAT ACT Celite Cartridges || in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
  • Manufacturer
    Abbott Point Of Care Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de iSTAT ACT Celite Cartridges
iSTAT ACT Kaolin Cartridges
  • Modelo / Serial
    List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    i-STAT ACT Kaolin Cartridges || in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
  • Manufacturer
    Abbott Point Of Care Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de iSTAT ACT Kaolin Cartridges
Pacific Hemostasis ThromboplastinDS
  • Modelo / Serial
    V40526, exp 4/2013 V40826, exp 4/2013
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey.
  • Descripción del producto
    Pacific Hemostasis ¿ Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** || Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
  • Manufacturer
    Fisher Diagnostics, A Company of Fisher Scientific LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Pacific Hemostasis ThromboplastinDS
CELLDYN Emerald
  • Modelo / Serial
    Serial numbers ending in  0063,0110,0196,0197,  0230,0281,0285,0293,  0319,0329,0332,0358,  0361,0362,0396,0435,  0440,0468,0474,0606,  0642, 0664, 0687, and  0719 through 1331
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.
  • Descripción del producto
    Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; || List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; || Product is distributed by || Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL || Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de CELLDYN Emerald
CYTOSTAT tetraCHROME" CD45FITC/CD4RD1/CD8ECD/CD3PC5
  • Modelo / Serial
    All lots since 08/2003
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay.
  • Descripción del producto
    CYTO-STAT¿ tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 || Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de CYTOSTAT tetraCHROME" CD45FITC/CD4RD1/CD8ECD/CD3PC5
CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5
  • Modelo / Serial
    All lots since 08/2003
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay.
  • Descripción del producto
    CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. || Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5
Factor II (prothrombin) G20210A kit
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.
  • Descripción del producto
    Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN || The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples snd fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aide to dignosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 instrument using the LightCycler Software 4.05 or 4.1.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Factor II (prothrombin) G20210A kit
Factor V Leiden kit
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.
  • Descripción del producto
    Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN || The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Factor V Leiden kit
HEMOCUE Hb 201 DM ANALYZER
  • Modelo / Serial
    HemoCue Hb 201 DM Analyzers, (USA): Serial Numbers:  0632620050; 0647620080, 0717620162 & 0717620185; 0650620105; 0717620156; 0717620169; 0717620186; 0647620088; 0717620170; 0717620157 & 0717620187;  0647620104, 0650620077, 0650620081, 0650620104, 0706620010, 0706620032, 0706620043, 0706620057, 0706620094, 0709620025 & 0709620031; 0650620066; 0650620112; 0717620152, 0717620153 & 0717620172; 0706620041; 0717620189; 0717620190; 0717620158; 0702620049; 0717620155; 0717620115; 0717620178 & 0717620179; 0717620159; 0717620065 & 0717620174; 0717620165; 0717620181; 0717620167; 0706620019 & 0706620020; 0717620171, 0717620173 & 0717620184; 0717620131; 0717620166, 0717620160, 0717620168 & 0717620180.  HemoCue Hb 201 DM Analyzers, (Europe): Serial Numbers:  0630630060; 0639620042; 0640620003 & 0640620015; 0717620197; 0717620199; 0717620183; 0717620191; 0717620200; 0709620026 & 0709620121; 0709620050, 0709620097, 0717620193, 0717620194, 0717620195 & 0717620196; 0717620163 & 0717620164; 0709620034; 0709620023; 0717620198; 0647620069.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
  • Descripción del producto
    HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
  • Manufacturer
    Hemo Cue, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de HEMOCUE Hb 201 DM ANALYZER
CellQuest Pro SW
  • Modelo / Serial
    Catalog numbers: 343926, 339455, 343928, 347527, and 347526.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    CellQuest Pro SW, version 4.0.2. and later; || Becton Dickinson, San Jose, CA 95131 || CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.
  • Manufacturer
    BD Biosciences, Systems & Reagents
  • 1 Event
    • Retiro De Equipo (Recall) de CellQuest Pro SW
Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat
  • Modelo / Serial
    Upgrade 37379, Upgrade 40963, Upgrade 41256, 47686, 47778, 47927, 47981, 48018, 48019, 48052, 48053, 48125, 48126, 48127, 48352, 48559, 46594, 47048, 47064, 47213, 47226, 47737, 47738, 47874, 47875, 48228, 48229, 48355, 48356, 46607, 46608, 48350, 46605, 47693, 48629, 48022, 48227, 48134, 46823, 46824, 48716, 43642.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the states of LA, OH, FL, MD, PA, TX, MO, WI, KS, AL, CA, VA, MS, IL, NE, MA, and the countries of Australia, Belgium, China, Czech Republic, Denmark, Estonia, Finnland, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Taiwan, and the UK.
  • Descripción del producto
    Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany || Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
  • Manufacturer
    Thermo Fisher Scientific
  • 2 Event
    • Retiro De Equipo (Recall) de Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat
    • Retiro De Equipo (Recall) de Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat
UniCel DxH 800 Coulter Cellular Analysis System
  • Modelo / Serial
    All serial numbers, SW version 1.1.3.0
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
  • Manufacturer
    Beckman Coulter Inc.
  • 4 Event
    • Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System
    • Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System
    • Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System
    • Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System
UniCel DxH 800 Floor Cabinet
  • Modelo / Serial
    All serial numbers, SW version 1.1.3.0
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel DxH 800 Floor Cabinet Part Number: 723335 || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de UniCel DxH 800 Floor Cabinet
UniCel DxH 800 Analyzer
  • Modelo / Serial
    All serial numbers, SW version 1.1.3.0
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
  • Descripción del producto
    UniCel DxH 800 Floor Cabinet Part Number: 723335 || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de UniCel DxH 800 Analyzer
Alere™ INRatio® PT/INR Monitor System
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Alere
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Alere™ INRatio® PT/INR Monitor System
NucliSENS® easyMAG® Magnetic Silica
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Biomerieux UK
  • 2 Event
    • Notificaciones De Seguridad De Campo acerca de NucliSENS® easyMAG® Magnetic Silica
    • Notificaciones De Seguridad De Campo acerca de NucliSENS® easyMAG® Magnetic Silica
Alere INRatio®/INRatio®2 PT/INR Monitoring System
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Alere San Diego Inc.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Alere INRatio®/INRatio®2 PT/INR Monitoring System
NucliSENS® easyMAG® Magnetic Silica; NucliSENS® Magnetic Extraction Reagents
  • Modelo / Serial
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Biomerieux
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de NucliSENS® easyMAG® Magnetic Silica; NucliSENS® Magnetic Extraction Reagents
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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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