Events

Device Recall ScanScope System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Biosystems Imaging, 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
    67418
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1152-2014
  • 사례 시작날짜
    2014-02-07
  • 사례 출판 날짜
    2014-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125499
  • 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
    Microscope, automated, image analysis, operator intervention - Product Code NOT
  • 원인
    In an abundance of caution, aperio (now known as lecia biosystems) is providing additional information to clarify that the use of digital ihc breast/er/dako image analysis, digital ihc breast/her2 digital read, digital ihc breast/her2/dako image analysis, digital ihc breast/pr digital read and digital ihc breast/pr/dako image analysis with the ruo products identified in that earlier notification i.
  • 조치
    Aperio (now known as Leica Biosystems) sent an recall notification letter on February 7, 2014, via USPS mail. The letter dated January 31, 2014, informed customers of the reason for the notification, product description, provided additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. The notice also included updated manuals for the image analysis algorthithms so that the intended use in the hardware and software manuals is consistent. An acknowledgement form and contact information was also provided. We sincerely apologize for any inconvenience this may have caused. If you have any questions, please do not hesitate to contact Aperio Technical Support at (866) 478-3999.

Device

Device Recall ScanScope System
  • 모델명 / 제조번호(시리얼번호)
    23elHCKIT2500, 23elHCKIT5000, 23elHCKIT500.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH.
  • 제품 설명
    HER2 Image Analysis || Manual Read of HER2 Digital Slides || ER/PR Image Analysis || IHC PR Breast Tissue Manual Read of Digital Slides || The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin¿¿ clinical outcome has not been established. Manual Read of HER2 Digital Slides: The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿ (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin¿¿ clinical outcome has not been established. ER/PR Image Analysis: The ScanScope¿¿ XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo
  • Manufacturer
    Leica Biosystems Imaging, Inc.

Manufacturer

Leica Biosystems Imaging, Inc.
  • 제조사 주소
    Leica Biosystems Imaging, Inc., 1360 Park Center DR, Vista CA 92081-8300
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA