Device Recall Access AccuTnI Assay

  • Modelo / Serial
    Lot Numbers: 911748, 913265, 913500, 915417, 915850, 916721, 916720, 916721A, 917611, 918533, 918666
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries of Algeria, Australia, Bangladesh, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Lebanon, Libyan Arab Jamahiriya, Monaco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Swaziland, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
  • Descripción del producto
    Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 || The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
  • Source