Device Recall Alere Triage CardioProfiler Panel

  • 모델명 / 제조번호(시리얼번호)
    Lot Code: W49569   Phase 2 (June 12, 2012): Lot#W49636
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait.
  • 제품 설명
    Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Phase 1:  W49604B, W49606B, W49607B, W49611B, W49612B, W49613B, W49614B, W49615B, W49616B, W49617B, W49620B, W49622B, W49623B, W49624B, W49625B, W49627B, W49628B, W49629B, W49630B, W49631B, W49633B, W49634B, W49635B, W49638B, W49639B, W50726B, W50727B, W50728B, W50731B, W50733B, W50734B, W50738B, and W50739B.  Phase 2:  W49609B, W49610B, W49618B, W49619B, W49626B, W49632B, W49640B, W50737B, and W50744B.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Alere Triage CardioProfiler Panel PN 97100CP || Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
  • Manufacturer