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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Device Recall Acumedia Nutrient Gelatin
  • Modelo / Serial
    PN 7471A, Lot 105550F
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
  • Descripción del producto
    Nutrient Gelatin, Acumedia Part Number 7471 A || Product Usage: || Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
  • Manufacturer
    Acumedia Manufacturers, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acumedia Nutrient Gelatin
Device Recall Acumedia Palcam Supplement
  • Modelo / Serial
    PN 7987, Lot 108044
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
  • Descripción del producto
    Palcam Supplement Acumedia PN 7987 || Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
  • Manufacturer
    Acumedia Manufacturers, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Acumedia Palcam Supplement
Device Recall VITEK 2 GP ID Test card
  • Modelo / Serial
    Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom
  • Descripción del producto
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. || VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITEK 2 GP ID Test card
Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
  • Modelo / Serial
    Product Code 1293254, Lot Code 1709228140
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
  • Descripción del producto
    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 || Diagnosis of Chagas disease.
  • Manufacturer
    Wiener Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
Device Recall Bimerieux
  • Modelo / Serial
    VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Bimerieux
Device Recall Biomerieux
  • Modelo / Serial
    VITEK 2 NH (ref: 21346): Lot Number 2450355203
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Biomerieux
Device Recall Biomerieux
  • Modelo / Serial
    VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Biomerieux
Device Recall Biomerieux
  • Modelo / Serial
    Oxidase Reagent (ref: 55635): Lot number 92366601
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Biomerieux
Device Recall Premier Toxin A
  • Modelo / Serial
    Lot #601096.180, Exp Date 27 SEP 03;  Kit Catalog #601096.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • Descripción del producto
    Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
    Meridian Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Premier Toxin A
Device Recall Premier Toxins A and B
  • Modelo / Serial
    Lot #616096.053, Exp Date 23 JUL 03; Lot #616096.055, Exp Date 23 JUL 03; Lot #616096.056, Exp Date 23 JUL 03;  Kit Catalog #616096.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • Descripción del producto
    Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
    Meridian Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Premier Toxins A and B
Device Recall Premier Platinum HpSA
  • Modelo / Serial
    Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070, Exp Date 22 SEP 03;  Kit Catalog #601348
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The kits were distributed to end-users and distributors located nationwide; and to foreign distributors located in China, Guatemala, New Zealand, Hong Kong, Mexico, Great Britain, Belgium, Italy, Brazil, Australia, Canada, Thailand, Honduras, and Japan.
  • Descripción del producto
    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
  • Manufacturer
    Meridian Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Premier Platinum HpSA
Device Recall Rapid IVD test kit for Chlamydia antigen..
  • Modelo / Serial
    Catalog No. CHL30, Lot No. 132117, 132117A,133101
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, and to France, New Zealand and Spain.
  • Descripción del producto
    Chlamydia OIA. For in vitro diagnostic use,
  • Manufacturer
    Thermo Biostar, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Rapid IVD test kit for Chlamydia antigen..
Device Recall Rapid IVD test kit for Chlamydia antigen..
  • Modelo / Serial
    Catalog No. CHLINT, Lot No. 133354, 133174. Foreign distribution.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, and to France, New Zealand and Spain.
  • Descripción del producto
    Chlamydia OIA. For in vitro diagnostic use.
  • Manufacturer
    Thermo Biostar, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Rapid IVD test kit for Chlamydia antigen..
iVIEW DAB Detecion Kit. || Catalog Number 760-091
  • Modelo / Serial
    Lot 400566
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    iVIEW DAB Detecion Kit. || Catalog Number 760-091
  • Manufacturer
    Ventana Medical Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de iVIEW DAB Detecion Kit. || Catalog Number 760-091
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) desi...
  • Modelo / Serial
    Lot No: 00008066; Expiration Date: 08-11-2001.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    NJ
  • Descripción del producto
    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
  • Manufacturer
    Zeus Scientific Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
Device Recall RAD SOURCE
  • Modelo / Serial
    Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Units were distributed to 20 blood banks and transfusion services in WI, KS, IN, MI, GA, NC, WA, NE, FL, IN, TX, MD, Washington DC, SC, and NM.
  • Descripción del producto
    RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
  • Manufacturer
    Rad-Source Technologies, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RAD SOURCE
Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
  • Modelo / Serial
    Lot 118
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
  • Descripción del producto
    Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
  • Manufacturer
    Diagnostic Products Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
Device Recall Remel QCSlide Gram Stain Control
  • Modelo / Serial
    Lot #001453, Exp. 2013-04-03
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.
  • Descripción del producto
    Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
  • Manufacturer
    Remel, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Remel QCSlide Gram Stain Control
Device Recall Directigen (TM) EZ RSV
  • Modelo / Serial
    lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
  • Descripción del producto
    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Directigen (TM) EZ RSV
Device Recall BioRad Laboratories
  • Modelo / Serial
    Lot number: 3F0001  Exp. 2004-05-15
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The firm distributed to hospitals and diagnostic laboratories nationwide.
  • Descripción del producto
    Platelia Aspergillus EIA
  • Manufacturer
    Bio Rad Laboratories, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BioRad Laboratories
Nitrate Reagent A, Cat No. Z71, Lot 3338 || Nitrate Reagent B, Cat No. A72, Lot 3338
  • Modelo / Serial
    Lot 3338.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    TX, CA, ID, Puerto Rico, KS, WY,
  • Descripción del producto
    Nitrate Reagent A, Cat No. Z71, Lot 3338 || Nitrate Reagent B, Cat No. A72, Lot 3338
  • Manufacturer
    Hardy Media Inc Dba Hardy Diag
  • 1 Event
    • Retiro De Equipo (Recall) de Nitrate Reagent A, Cat No. Z71, Lot 3338 || Nitrate Reagent B, Cat No. A72, Lot 3338
Device Recall Binax
  • Modelo / Serial
    Lot # 015168 and 015172
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
  • Descripción del producto
    NOW RSV Test || Item Number 430-430, Kit Number 430-00R
  • Manufacturer
    Binax, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Binax
Array Systems Calibrator 5 || Part No. 465250
  • Modelo / Serial
    Lot M305283
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Descripción del producto
    Array Systems Calibrator 5 || Part No. 465250
  • Manufacturer
    Beckman Coulter Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Array Systems Calibrator 5 || Part No. 465250
Device Recall ABBOTT TestPackPlus Strep A with On Board Controls (OBC) II
  • Modelo / Serial
    List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200.    List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany
  • Descripción del producto
    ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ABBOTT TestPackPlus Strep A with On Board Controls (OBC) II
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
  • Modelo / Serial
    Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Descripción del producto
    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
  • Manufacturer
    Gen Probe Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
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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.