Events

Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems 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
    55164
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2771-2011
  • 사례 시작날짜
    2009-05-07
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90200
  • 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
    Antibody Radioassay - Product Code LIG
  • 원인
    The recall was initiated after beckman coulter confirmed reports of inaccurate access intrinsic factor ab test results displayed on, or printed from, the unicel dxl portion of an integrated workstation listed above. the problem is limited to numerical intrinsic factor ab results produced on integrated systems running unicel dxl system software version 4.0, 4.1, or 4.2. the dxc portion of your inte.
  • 조치
    Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.

Device

Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.
  • 제품 설명
    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems || The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements
  • 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