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  • Dispositivo 1004
  • Fabricante 31827
  • Evento 1040
  • Implante 0
Device Recall CELLDYN Ruby System
  • Modelo / Serial
    Affected serial numbers:  70002BG 70026BG 70050BG 70076BG 70105BG 70141BG 70003BG 70028BG 70051BG 70077BG 70106BG 70142BG 70004BG 70029BG 70052BG 70079BG 70107BG 70144BG 70005BG 70030BG 70054BG 70082BG 70113BG 70146BG 70006BG 70031BG 70056BG 70084BG 70114BG 70147BG 70007BG 70032BG 70058BG 70086BG 70119BG 70149BG 70008BG 70033BG 70059BG 70087BG 70120BG 70164BG 70009BG 70034BG 70061BG 70088BG 70124BG 70165BG 70010BG 70035BG 70063BG 70089BG 70125BG 70166BG 70011BG 70036BG 70064BG 70090BG 70127BG 70167BG 70012BG 70037BG 70065BG 70091BG 70129BG 70170BG 70013BG 70038BG 70067BG 70092BG 70130BG 70171BG 70014BG 70039BG 70068BG 70093BG 70131BG 70178BG 70016BG 70040BG 70069BG 70094BG 70132BG 70181BG 70018BG 70042BG 70070BG 70095BG 70133BG 70183BG 70019BG 70043BG 70071BG 70096BG 70134BG 70189BG 70020BG 70044BG 70072BG 70099BG 70136BG 70021BG 70045BG 70073BG 70100BG 70137BG 70024BG 70046BG 70074BG 70103BG 70138BG 70025BG 70047BG 70075BG 70104BG 70140BG.  UPDATE: 2-28-17 - five additional serial numbers added: 55899BG,  55900BG,  55901BG,  55902BG  55904BG.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg.
  • Descripción del producto
    CELL-DYN Ruby System: || List Number: 08H6701; || Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CELLDYN Ruby System
Device Recall NucliSENS Lysis Buffer, REF 200292
  • Modelo / Serial
    Lot Number 16092902
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.
  • Descripción del producto
    NucliSENS Lysis Buffer, REF 200292 || NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall NucliSENS Lysis Buffer, REF 200292
Device Recall Sysmex XN Series Automated Hematology Analyzers
  • Modelo / Serial
    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada
  • Descripción del producto
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  • Manufacturer
    Sysmex America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sysmex XN Series Automated Hematology Analyzers
Device Recall Shandon Rapid Chrome KwikDiff
  • Modelo / Serial
    Part Number: 9990700 Lot Number S-645, S-646 and S-647 Part Number 9990707 Lot: 234, 235, and 236  Expiration date: 8/18/2018-12/10/2018
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.
  • Descripción del producto
    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 || Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 || Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. || Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. || Intended for use as a kit in special stain techniques.
  • Manufacturer
    Richard-Allan Scientific Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Shandon Rapid Chrome KwikDiff
Device Recall Estrogen Receptor (EP1)
  • Modelo / Serial
    7.0 ml lot 1326605C; expiry 2018-06; 1.0 ml lot 14035068; expiry 2017-01.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    Estrogen Receptor (EP1) || 7.0 mL Catalog number 249R-28; || 1.0 mL Catalog number 249R-16 || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Estrogen Receptor (EP1)
Device Recall Estrogen Receptor (SP1)
  • Modelo / Serial
    7.0 ml lot 1603506A , expiry 201 9-01;  lot 1422402D/1422402L, expiry 2017-07.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    Estrogen Receptor (SP1) || 7.0 mL Catalog number 249R-18; || Hematology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Estrogen Receptor (SP1)
Device Recall SV40 (MRQ4)
  • Modelo / Serial
    lot 1416002H, expiry 2017-05
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    SV40 (MRQ-4) || 0.5 ml catalog number 351 M-15. || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SV40 (MRQ4)
Device Recall CD117, ckit (YR145)
  • Modelo / Serial
    1.0 ml lot 16175038, expiry 2019-05;  7.0 mL lot 1617502A, expiry 2019-05; lot 16175020, expiry 2019-05 and lot 1511403J, expiry 2018-03.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    CD117, c-kit (YR145) || 1.0 ml catalog number 117R-16 || 7.0 ml catalog number-18 || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall CD117, ckit (YR145)
Device Recall HHV8 (13B10)
  • Modelo / Serial
    1.0 ml lot 1626403D, expiry 2019-08; 7.0 mL lot. 1625207H, expiry 2019-08;
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    HHV-8 (13810); || 1.0 ml catalog number 265M-16; || 7.0 ml catalog number-265M-18; || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HHV8 (13B10)
Device Recall Pacific Hemostasis Fibrinogen Degradation Products
  • Modelo / Serial
    Lot Number 948546, Exp. 9/30/2017
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • Descripción del producto
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
  • Manufacturer
    Fisher Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pacific Hemostasis Fibrinogen Degradation Products
Device Recall Pacific Hemostasis FDP Latex Reagent
  • Modelo / Serial
    Lot Number 890199, Exp. 6/30/2018
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • Descripción del producto
    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
  • Manufacturer
    Fisher Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pacific Hemostasis FDP Latex Reagent
Device Recall Tissue Processor
  • Modelo / Serial
    Serial No. 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 238, 240, 242, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 290, 292, 294, 296, 298, 300, 302, 304, 308, 312, 320, 334, 336, 338, 340, 342, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 378, 380, 382, 384, 386, 388, 396, 400, 402, 406, 408, 418, 420, 422, 424, 426, 428, 432, 434, 438, 440, 442, 444, 450, 452, 454, 456, 460, 462, 464, 468, 478, 480, 482, 484, 486, 488, 490, 492, 498, 502, 504, 516, 526, 530, 536, 544, 546, 548, 550, 554, 556, 558, 560, 562, 564, 570, 572, 574, 576, 580, 582, 584, 586, 588, 590, 598, 604, 612, 614, 628, 632, 636, 640, 642, 646, 650, 654, 660, 662, 666, 668, 674, 676, 684, 686, 692, 694, 696, 698, 700, 702, 704, 706, 712, 718, 720, 726, 728, 730, 732, 734, 736, 738, 742, 744, 746, 770, 784, 794, 796, 808, 810, 814, 816, 818, 820, 824, 834, 858, 860, 864, 866, 868, 870, 874, 878, 886, 892, 314, 316, 448, 538, 594, 622, 712, 778.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.
  • Descripción del producto
    Nussloch GmbH ASP6025 Tissue Processor
  • Manufacturer
    Leica Microsystems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Tissue Processor
Device Recall HbA1c
  • Modelo / Serial
    Lot/Batch 414553, expiry 28th Jan 2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
  • Descripción del producto
    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml || HbA1c R2: Agglutinator Reagent - 3 x 14 ml || R3: Haemoglobin Denaturant Reagent - 3 x 50 ml || Hb R1: Total Haemoglobin Reagent - 3 x 28 ml || For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
  • Manufacturer
    Randox Laboratories Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HbA1c
Device Recall Beckman Coulter Slidemaker Stainer
  • Modelo / Serial
    P/N A85371AA20; Catalog No. 775222
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
  • Descripción del producto
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. || The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. || Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Beckman Coulter Slidemaker Stainer
Device Recall COULTER Hematology Analyzers: LH 750; LH 500, and LH 780
  • Modelo / Serial
    Catalog Number(s): LH 750 System - 6605632, A85570, A68807; LH 780 System - 723585, A90728, A68808; LH 500 system - 6605525, 6605526, 6605527, A85566, A85564; All software versions
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.
  • Descripción del producto
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers || Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall COULTER Hematology Analyzers: LH 750; LH 500, and LH 780
Device Recall COULTER HmX Hematology Analyzer
  • Modelo / Serial
    Catalog Number(s): HMX CP - 178832, 178833, 178834, A91062, A90994; HmX AutoLoader - 6605522, 6605523, 6605524; All software versions.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.
  • Descripción del producto
    Coulter HmX CP and Coulter HmX AL Analyzers || The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall COULTER HmX Hematology Analyzer
Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Ste...
  • Modelo / Serial
    Lot number 17DAH349
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : NC, UT, OR, NY,TX, GA, NJ and FL.
  • Descripción del producto
    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
  • Manufacturer
    Cardinal Health 200, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape
Device Recall AQUIOS CL Flow Cytometer System
  • Modelo / Serial
    All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
  • Descripción del producto
    AQUIOS CL Flow Cytometer System || The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AQUIOS CL Flow Cytometer System
Device Recall Podoplanin (D240) antibody
  • Modelo / Serial
    Product Code PA0796, Lot No. 47793, Exp. Date 09/24/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Podoplanin (D240) antibody
Device Recall Glypican3 (1G12 Mab) CM
  • Modelo / Serial
    Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Glypican3 (1G12 Mab) CM
Device Recall Microphthalmia Transcription Factor
  • Modelo / Serial
    Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Microphthalmia Transcription Factor
Device Recall MSH6 (44 Mab) CM
  • Modelo / Serial
    Product Code PA0804, Lot No. 45973, Exp. Date 05/21/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MSH6 (44 Mab) CM
Device Recall Napsin A (MRQ60 Mab) CM
  • Modelo / Serial
    Product Code PA0805, Lot No. 46349, Exp. Date 06/11/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, || The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Napsin A (MRQ60 Mab) CM
Device Recall PAX8 (MRQ50 Mab) CM
  • Modelo / Serial
    Product Code PA0808, Lot No. 47795, Exp. Date 09/24/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PAX8 (MRQ50 Mab) CM
Device Recall SOX10 (Polyclonal) CM
  • Modelo / Serial
    Product Code PA0813, Lot No. 47800, Exp. Date 09/24/2019
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Descripción del producto
    Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing..
  • Manufacturer
    Leica Biosystems Richmond Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SOX10 (Polyclonal) CM
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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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