Events

Device Recall PrepStain System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tripath 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
    62117
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2086-2012
  • 사례 시작날짜
    2011-12-08
  • 사례 출판 날짜
    2012-07-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109892
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • 원인
    Some prep stain kit, 1.2 diti cones have been found to be leaking and the prepstain preparation kits contain incorrect preventive maintenance (pm) instructions.
  • 조치
    BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.

Device

Device Recall PrepStain System
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 491074: Serial/Lot # 110805MA
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • 제품 설명
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • 제조사 주소
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA