Events

Device Recall UniCel DxH 800 Coulter Cellular Analysis System 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
    55194
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1656-2010
  • 사례 시작날짜
    2010-03-02
  • 사례 출판 날짜
    2010-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90277
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    Issue 1: the diagnostic procedure, simulate-cdnr cycle, is not functioning properly. impact: there is a potential for inadequate sample preparation of samples following the use of this diagnostic function impacting wbc, differential, reticulocyte and/or nrbc results. issue 2: use of the auto prune function causes the deletion of quality control files. impact: if the last run for a control lot.
  • 조치
    Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated March 10, 2010. Consignees were informed of the affected product and instructed on proper steps to take and requested to return the enclosed acknowledgement form. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

Device

Device Recall UniCel DxH 800 Coulter Cellular Analysis System
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and Canada.
  • 제품 설명
    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA