ARCHITECT i System Assay CDROM WW (excluding USA accounts)

  • Modelo / Serial
    LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts.
  • Descripción del producto
    ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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