Events

Discovery Ultra Advanced Staining System Research Use Only (RUO) 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
    64244
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0834-2013
  • 사례 출판 날짜
    2013-08-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115667
  • 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
    Slide stainer, automated - Product Code KPA
  • 원인
    Potential for a waste fluid overflow condition to accur while running decontamination cycles on the benchmark ultra automated staining platform or the discovery ultra automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. this type of overflow event can lead to migration of flu.
  • 조치
    The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.

Device

Discovery Ultra Advanced Staining System Research Use Only (RUO)
  • 모델명 / 제조번호(시리얼번호)
    Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and country of: Germany.
  • 제품 설명
    VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only || Product Usage: || Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • 제조사 주소
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Oro Valley AZ 85755-1962
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    USFDA