AxSYM Homocysteine

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
    LAANSM

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  • 모델명 / 제조번호(시리얼번호)
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
  • 제품 설명
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer