Events

Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter 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
    46370
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1529-2008
  • 사례 시작날짜
    2007-08-20
  • 사례 출판 날짜
    2008-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67307
  • 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
    Differential cell counter - IVD - Product Code GKZ
  • 원인
    Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
  • 조치
    A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.

Device

Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager
  • 모델명 / 제조번호(시리얼번호)
    All Software Versions
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and country of Canada.
  • 제품 설명
    Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 || A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • 제조사 주소
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA