Device Recall iView DAB Detection Kit 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
    58855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2717-2011
  • 사례 시작날짜
    2011-05-16
  • 사례 출판 날짜
    2011-07-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Immunohistochemistry antibody assay, estrogen receptor - Product Code MYA
  • 원인
    The recall was initiated because ventana medical systems, inc. (ventana), has identified the presence of precipitate in some dab chromogen dispensers in two lots of ultraview universal dab detection kit (part number 760-500, lot a05885 and lot b00988) and one lot of iview dab detection kit (part number 760-091, lot b01057a.).
  • 조치
    The firm, Ventana, sent two letters dated May 16, 2011, an "URGENT Medical Device Recall" notice to customers who received the affected lots and an "URGENT Medical Device Correction" to customers of unaffected lots. The letters described the product, problem and actions to be taken. The customers were instructed to discontinue use of any kits from the lots identified above; follow their internal standard operating procedures for assessing potential impact to reported patient results, If their laboratory had already used kits from these lots; conduct visual inspections of any DAB chromogen dispensers in use as part of their daily maintenance routine; inspect their current inventory and contact their local customer support team (800-227-2155) to replace any unused or partially used kits from the affected lots. Ventana highly recommends use of same-slide controls, especially when testing for targets of therapy, to mitigate any impact on patient results. If you find a dispenser containing precipitate in lots not identified in this letter or have any questions and concerns, please notify/contact your local customer support team (800-227-2155) .

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number: B01057A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • 제품 설명
    iView DAB Detection Kit, Part number: 760-091 || (05266157001) || This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
  • Manufacturer

Manufacturer

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