ARCHITECT Clinical Chemistry Analyser

  • Modèle / numéro de série
    Product Name: ARCHITECT c4000, ARCHITECT c8000, ARCHITECT c16000. List Number: 2P24-01, 2P24-40, 1G06-11, 3L77-01 Instrument Serial Numbers: c460004 to c460014, c460016 to c460019, c400069, c400071 to c400099, c400146, c400219, c800307, c800742, c801237, c801462, c802378, c803060, c803061, c803062, c803063, c1600284
  • Description du dispositif
    Processing Module System For In Vitro Diagnostic Use
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.
  • Représentant du fabricant
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA