ARCHITECT Instrument

  • Modelo / Serial
    c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution to US, Canada, France, and Germany.
  • Descripción del producto
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source