Events

EnVision FLEX, EnVision FLEX, EnVision FLEX Mini 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
    72097
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0220-2016
  • 사례 시작날짜
    2015-09-04
  • 사례 출판 날짜
    2015-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139936
  • 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
    Reagent, general purpose - Product Code LDT
  • 원인
    There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
  • 조치
    Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.

Device

EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit
  • 모델명 / 제조번호(시리얼번호)
    Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis)  Catalog/Model No.: K8000 K8002 K8023 GV800  SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362  DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102
  • 유통
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.
  • 제품 설명
    EnVision FLEX/HRP visualization reagent found in the following kits: || EnVision FLEX, High pH (Link) || EnVision FLEX+, Mouse, High pH (Link) || EnVision FLEX Mini Kit, High pH (Link) || EnVision FLEX, High pH (Dako Omnis) || Multi-component, sealed package. For in vitro diagnostic use.
  • 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