Device Recall Abbott Point of Care Inc

  • 모델명 / 제조번호(시리얼번호)
    All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
  • 제품 설명
    i-Stat PT/INR Cartridges || List number 03P89-24 || The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. || a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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
    USFDA