Events

Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnostic 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-2015-RN-00143-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-03-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00143-1
  • 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 is advising the users that it is releasing access 2 system software version 3.4.2 and access 2i (unicel dxc 600i system) software version 6.2.2 to address the reagent pack volume issues notification that was distributed august 13, 2010. the notification discussed the risks associated with assay reagent packs that were loaded incorrectly, or reagent packs that were inappropriately transferred between two systems (pack sharing). with these software versions, the new reagent pack monitoring feature enables the access 2 system pressure monitoring hardware to detect packs with insufficient volume, as well as packs that are improperly loaded or missing.
  • 조치
    Beckman Coulter is providing customer-installable 3.4.2 or 6.2.2 software disc along with an information packet that describes the new reagent pack monitoring feature to all customers in Australia. This action has been closed-out on 20/06/2016.

Device

Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnos...
  • 모델명 / 제조번호(시리얼번호)
    Access 2 Immunoassay Systems Catalogue numbers: 81600N, 386220, A69186, A12900, A56158, A65531UniCel DxC 600i SYNCHRON Access Clinical System Catalogue numbers: A25640, A25638, A25637, A25635, A25656, A25634An in vitro diagnostic device (IVD)ARTG Number: 177999
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd