Events

Device Recall CD99 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biocare Medical, LLC 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
    70823
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1535-2015
  • 사례 시작날짜
    2015-03-17
  • 사례 출판 날짜
    2015-04-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134965
  • 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
    A drop in staining intensity over time has been observed. these lots may not meet their labeled shelf life.
  • 조치
    Biocare sent a Medical Device Notification letters dated March 17, 2015 to all affected sites. The letters identify the affected product, problem, actions to be taken and the fact that it affects all identified lots shipped between 02/13/13 and / 01/28/15. The letters instructed customers to immediately discontinue further use of the recalled lots, dispose of them according to state and local regulations and complete the response form and returned by April 7, 2015. Credit will be issued upon receipt of the response form.

Device

Device Recall CD99
  • 모델명 / 제조번호(시리얼번호)
    Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
  • 제품 설명
    CD99 || Catalog number PM008 AA; || For In Vitro Diagnostic Use. || Product Usage: || Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
  • Manufacturer
    Biocare Medical, LLC

Manufacturer

Biocare Medical, LLC
  • 제조사 주소
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • 제조사 모회사 (2017)
    Biocare Medical LLC
  • Source
    USFDA