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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Zoll Medical
  • Modelo / Serial
    Software Versions below 34.00
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Zoll M Series Automated Defibrillator (AED)
  • Manufacturer
    Zoll Medical Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Zoll Medical
Xpert Infinity Software
  • Modelo / Serial
    V 4.1a
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia.
  • Descripción del producto
    Xpert Infinity Software, V 4.1a. || Cepheid, Sunnyvale, CA 94089 || system software for GeneXpert Infinity 48
  • Manufacturer
    Cepheid
  • 1 Event
    • Retiro De Equipo (Recall) de Xpert Infinity Software
Xpert GBS
  • Modelo / Serial
    Lot Number : 1402
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
  • Manufacturer
    Cepheid
  • 1 Event
    • Retiro De Equipo (Recall) de Xpert GBS
Xpert CT/NG
  • Modelo / Serial
    Lot numbers: 25718, 25719, 25725, and 25727.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Puerto Rico, and Haiti.
  • Descripción del producto
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. || Is a qualitative in vitro real-time PCR test.
  • Manufacturer
    Cepheid
  • 1 Event
    • Retiro De Equipo (Recall) de Xpert CT/NG
Xpect Giardia/Cryptosporidium Kit
  • Modelo / Serial
    Lot numbers 597374, Exp. 2008.10.08; 607636, Exp. 2008.11.06; 615970, Exp. 2008.12.02; 615971, Exp. 2008.12.02; 621187, Exp. 2008.12.02; 622617, Exp. 2009.04.02; 624618, Exp. 2009.01.02; 635553, Exp. 2009.04.17; 635554, Exp. 2009.04.24; 640609, Exp. 2009.05.01; 654829, Exp. 2009.05.30; and 658878, Exp. 2009.05.30
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada and U.K.
  • Descripción del producto
    Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. || A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.
  • Manufacturer
    Remel, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Xpect Giardia/Cryptosporidium Kit
West Nile Virus IgM Capture ELISA
  • Modelo / Serial
    Lot 07262 (Canada), and Lot 08118 (Four customers in USA)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including ND, PA, TX, MN; and the country of Canada
  • Descripción del producto
    West Nile Virus IgM Capture ELISA || The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics.
  • Manufacturer
    Inverness Medical
  • 1 Event
    • Retiro De Equipo (Recall) de West Nile Virus IgM Capture ELISA
West Nile Virus IgG DxSelect
  • Modelo / Serial
    Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
  • Descripción del producto
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G || Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen || Wells, Catalog Number EL0351, Lot Number 121117. || 510(k) No. K031953 || The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event
    • Retiro De Equipo (Recall) de West Nile Virus IgG DxSelect
WELCH ALLYN PIC 50
  • Modelo / Serial
    Model Catalog: 971084 (Lot serial: 82025)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Descripción del producto
    WELCH ALLYN PIC 50 DEFIBRILLATOR
  • Manufacturer
    ROXON MEDI-TECH LTD.
  • 1 Event
    • Retiro De Equipo (Recall) de WELCH ALLYN PIC 50
WASP (Walk Away Specimen Process) Instrument software
  • Modelo / Serial
    Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan
  • Descripción del producto
    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument || Catalog number: W086 || WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
  • Manufacturer
    Copan Italia
  • 1 Event
    • Retiro De Equipo (Recall) de WASP (Walk Away Specimen Process) Instrument software
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pa...
  • Modelo / Serial
    Lot #750, Exp. 14 January 2004
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J; International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
  • Descripción del producto
    Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic med...
  • Modelo / Serial
    VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic medical device (IVD)VITROS Immunodiagnostic Products CA 19-9 CalibratorsProduct Code: 6800035VITROS Immunodiagnostic Products CA 19-9 Reagent PackProduct Code: 6800040Lot Number: 1320Expiry Date: 12 September 2014
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic medical device (IVD)
VITROS Immunodiagnostic Products CA 125 II Calibrators
  • Modelo / Serial
    product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
  • Descripción del producto
    VITROS CA 125 II Calibrators || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products CA 125 II Calibrators
VITROS Immunodiagnostic Products AntiHCV Reagent Pack
  • Modelo / Serial
    Lot 9090 (exp. December 15, 2014)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    NY, NJ, CT, MA, PA, VA, MD, FL and GA
  • Descripción del producto
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products AntiHCV Reagent Pack
VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs
  • Modelo / Serial
    Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution - all states.
  • Descripción del producto
    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products AntiHBs Calibrators & AntiHBs Reagent Packs
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Di...
  • Modelo / Serial
    Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J; foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.
  • Descripción del producto
    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per ...
  • Modelo / Serial
    Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J; affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.
  • Descripción del producto
    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.
Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990...
  • Modelo / Serial
    Coatings 401 thru 419.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
  • Descripción del producto
    Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.
VITROS Chemistry Products CRP Slides
  • Modelo / Serial
    Affected Generations (GENs): 3, 11, 12, 30 through 36
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de VITROS Chemistry Products CRP Slides
VITEK GPS107 Gram Positive Susceptibility Card
  • Modelo / Serial
    Lot #B28E
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines.
  • Descripción del producto
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Manufacturer
    bioMerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK GPS107 Gram Positive Susceptibility Card
VITEK GPS107 Gram Positive Susceptibility Card
  • Modelo / Serial
    Lot #P108X
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
  • Descripción del producto
    VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • Manufacturer
    bioMerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK GPS107 Gram Positive Susceptibility Card
Vitek 2 YST ID
  • Modelo / Serial
    2430199103 13/Jun/18 2430199123 13/Jun/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 YST ID
Vitek 2 NH ID
  • Modelo / Serial
    2450129203 04/Apr/18 2450162203 07/May/18 2450204203 18/Jun/18 2450221203 05/Jul/18 2450288203 10/Sep/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Vitek 2 NH ID
Vitek 2 Gram Positive Susceptibility Test Cards
  • Modelo / Serial
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Biomerieux
  • 1 Event
    • Alerta De Seguridad para Vitek 2 Gram Positive Susceptibility Test Cards
VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
  • Modelo / Serial
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Descripción del producto
    Medical Device Safety Alert: BioMerieux VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
  • Manufacturer
    BioMerieux
  • 1 Event
    • Alerta De Seguridad para VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
VITEK 2 Gram Negative Susceptibility Card, ASTN184
  • Modelo / Serial
    All lot numbers
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    There was no U.S. distribution as the cards were for export only to Canada and Sweden.
  • Descripción del producto
    VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. || The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTN184
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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.