Events

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia Pty Ltd 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
    RC-2013-RN-01021-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01021-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    An internal investigation indicates that specific lots of check valves used in several locations within the dxh 800 and dxh 600 systems may fail. a failure may result in an air or liquid leak at the vcs waste chamber or probe waste chamber.
  • 조치
    End users are advised that if they experience a "Vent/overflow chamber detected overflow" error message, the three samples prior to the error message must be reviewed. Physical contact with leaks should be avoided by continuing to use protective equipment. A service representative will contact each customer to schedule an on-site visit for check valve inspection of any affected valves.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medic...
  • 모델명 / 제조번호(시리얼번호)
    UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)UniCel DxH 800 Coulter Cellular Analysis SystemProduct Number: 629029UniCel DxH 600 Coulter Cellular Analysis SystemProduct Number: B23858
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd