Events

Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (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-2012-RN-01160-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01160-1
  • 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 identified a potential problem in two pulley drive components in the mixer pulley assemblies of these systems.It has been determined that in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. beckman coulter is in the process of producing replacement components and will be installing them in every access/access 2 immunoassay, synchron lxi 725 clinical, and unicel dxc 6001 synchron access clinical system in the field.
  • 조치
    Beckman Coulter is providing work around instructions to mitigate the risk and replacing the mixer pulley assemblies to permanently fix the problem.

Device

Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel ...
  • 모델명 / 제조번호(시리얼번호)
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd