Events

PATHWAY HER2 (4B5) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ventana Medical Systems Inc 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
    53597
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1146-2010
  • 사례 시작날짜
    2009-09-17
  • 사례 출판 날짜
    2010-03-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85961
  • 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 - Product Code MVC
  • 원인
    Incorrect result: light staining inconsistencies with lot number 680957 of the ventana pathway her-2/neu (4b5) rabbit monoclonal primary antibody.
  • 조치
    The recall was initiated on 09/17/2009 with Ventana Medical Systems forwarding Urgent Voluntary Medical Device Recall letters to all the affected customers advising them to discontinue the use of lot number 680957 and have their laboratory retest with product from a different lot of PATHWAY HER2 (4B5) any breast cases scored as 0, 1+, or 2+ that were not reflexed to an approved in situ hybridization (ISH) method. Customers were also instructed to contact Ventana Customer Support at 1-800-227-2155 and select 1 for Technical Support to speak to a Customer Support agent who will work with then to replace or credit any product from this specific lot number.

Device

PATHWAY HER2 (4B5)
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 680957
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
  • 제품 설명
    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY || (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • 제조사 주소
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    USFDA