Device Recall Access Total T4 Reagent Kit

  • Modelo / Serial
    Lot Numbers (s): All reagent pack lots
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, and Zambia
  • Descripción del producto
    Access Total T4 Reagent Kit, Part Number: 33800, || Lot Numbers (s): All reagent pack lots || The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
  • Manufacturer
  • 1 Event

Fabricante

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