Events

Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). 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-2014-RN-01087-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01087-1
  • 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
    Beckman coulter has determined that the access 2 console pc (b23083) may experience an “mfc exception” error during normal operation. if this error occurs, the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a “0==itubescancount” event. if the ui is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same “mfc exception” error will occur. the access 2 console pc ui error can cause a delay in reporting of results, but will not cause erroneous results.
  • 조치
    Beckman Coulter service representative will contact affected customers and schedule a service visit to modify their Console PC. In the interim, customers are advised to continue operating their systems normally and contact Beckman Coulter Customer Support Centre if the error occurs. This action has been closed-out on 20/04/2017.

Device

Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON A...
  • 모델명 / 제조번호(시리얼번호)
    Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). An in vitro diagnostic medical device (IVD)Ref.: B23083 (small PC with silver faceplate)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd