Events

LEICA BIOSYSTEMS NEWCASTLE LTD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems, 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
    73802
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1877-2016
  • 사례 시작날짜
    2016-04-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145004
  • 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 reagents and kits - Product Code NJT
  • 원인
    Testing of retained units indicated that lot numbers of cdx2 indicated are not stable up to the expiry date on the product labeling.
  • 조치
    An Urgent: Medical Device Recall Notification dated 4/5/2016 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent¿ Complete the attached Recall Notification Acknowledgement Form that this action has been undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to LMGRA@Leica-Microsystems.com to receive credit for affected lots that have been destroyed by the consignees laboratory.

Device

LEICA BIOSYSTEMS NEWCASTLE LTD
  • 모델명 / 제조번호(시리얼번호)
    1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
  • 제품 설명
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA