Events

10 NBF 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard-Allan Scientific Company 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
    69276
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0018-2015
  • 사례 시작날짜
    2014-09-17
  • 사례 출판 날짜
    2014-10-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130173
  • 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
    Fixative, formalin-containing - Product Code LDY
  • 원인
    The affected lots could have nbf concentrations that are lower or higher than the desired specifications.
  • 조치
    The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com.

Device

10 NBF
  • 모델명 / 제조번호(시리얼번호)
    Product Code: C4320-450B Lot Number: 300403
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
  • 제품 설명
    Cardinal Health Prefilled Buffered 10% Formalin. || Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • 제조사 주소
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA