Events

Device Recall ADVIA Centaur TnIUltra Assay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    44725
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0580-2008
  • 사례 시작날짜
    2007-06-07
  • 사례 출판 날짜
    2008-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64326
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    in vitro diagnostic (Troponin) - Product Code MMI
  • 원인
    Incorrect results: falsely elevated troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other troponin assays.
  • 조치
    Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.

Device

Device Recall ADVIA Centaur TnIUltra Assay
  • 모델명 / 제조번호(시리얼번호)
    All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
  • 제품 설명
    ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • 제조사 주소
    Siemens Medical Solutions Diagnostics, 511 Benedict Avenue, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA