Events

Device Recall QCA and iQCA Software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems, 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
    50163
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1040-2009
  • 사례 시작날짜
    2008-11-06
  • 사례 출판 날짜
    2009-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74885
  • 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
    Digital Analyzer - Product Code NQN
  • 원인
    A change in the software to open up the software architecture to include other analytes other than estrogen receptor was made without fda review and approval.
  • 조치
    Leica Microsystems sent Medical Device Correction letters dated 11/6/08 to the direct accounts, informing them that all versions 3.7 and above of QCA and iQCA software are not in compliance with the original 510(k) cleared software for scoring of immunohistochemical stains in clinical applications. The QCA/iQCA software is only cleared for Estrogen Receptor staining under clinical applications. The accounts were provided with red warning stickers that state: "WARNING The clinical application of QCA software has been cleared only for the measurement of images from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuclear receptor protein only. Performance characteristics of the product, when used outside of this intended use, have not been established." They were instructed to apply the stickers to any existing manuals and or at each point of use, and to instruct all users about the notification. The accounts were also requested to complete and return the enclosed reply form confirming that the changes have been made.

Device

Device Recall QCA and iQCA Software
  • 모델명 / 제조번호(시리얼번호)
    all software versions 3.7 and above
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- including states of CA, IL, KS, and NY.
  • 제품 설명
    QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. || Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA