Events

Device Recall Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1 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
    45945
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0958-2008
  • 사례 시작날짜
    2007-06-29
  • 사례 출판 날짜
    2008-04-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66549
  • 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
    Automated differential cell counter - Product Code GKZ
  • 원인
    Data generation error: if the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
  • 조치
    Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.

Device

Device Recall Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144, AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100, AK24164, AJ47338, AJ13070, AL06029, AJ13071, AK32212, AK32210, AJ39264, AJ43304
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- USA and country of Canada.
  • 제품 설명
    Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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