Events

Device Recall Dako HER2 CISH pharmDx kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dako North America 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
    67380
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1093-2014
  • 사례 시작날짜
    2014-01-21
  • 사례 출판 날짜
    2014-02-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125376
  • 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
    Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer - Product Code NYQ
  • 원인
    Dako has initiated a recall of her2 cish pharmdxtm kit because weak red signals have been observed.
  • 조치
    Dako sent a Recall Notification letter dated January 21, 2014to affected customers via mail. The letter identified the affected product, description of the problem, actions to be taken by the user, communication, and Dako contact information. The letter was accompanied by a "Recall Form (Product Recall Form to customers)". For questions call 805-566-5464.

Device

Device Recall Dako HER2 CISH pharmDx kit
  • 모델명 / 제조번호(시리얼번호)
    Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and in the country of Chile.
  • 제품 설명
    Product Name: HER2 CISH pharmDx Kit || Catalog/Model number: SK109, lot 20000910 || Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • 제조사 주소
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • 제조사 모회사 (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA