CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD)

  • 모델명 / 제조번호(시리얼번호)
    CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD)List number: 09H46-02Lot numbers: 6853, 6901Expiry date: 31 July 2017Lot number: 6953Expiry date: 30 Sep 2017Lot Numbers: 6991Expiry date: 30 Nov 2017Lot Numbers: 7024, 7027Expiry date: 31 Dec 2017Lot Number: 7044Expiry date: 31 Jan 2018Lot Number: 7082Expiry date: 28 Feb 2018Lot Number: 7110Expiry date: 31 Mar 2018Lot Number: 7119Expiry date:30 Apr 2018ARTG number: 225068
  • Manufacturer
  • 1 Event

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    DHTGA