Access 2 Immunoassay Systems(Includes the Access 2 Immunoassay System and 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-00488-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-12
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 updated the instructions for use (ifu) to include the recommended temperature restrictions to address the impact of room temperature changes on certain assays run on access 2 immunoassay systems. the new updated operation range temperatures are between 18 to 28 degrees celsius. an updated version of the ifu is available on the beckman coulter website ( http://www.Beckmancoulter.Com).
  • 조치
    Beckman Coulter is notifying their customers that the updated version of the Access 2 Immunoassay Systems IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) This action has been closed-out on 19/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Access 2 Immunoassay Systems(Includes the Access 2 Immunoassay System and UniCel DxC 600i Synchron Access Clinical System)An in vitro diagnostic device (IVD)All Serial Numbers All Software Versions
  • Manufacturer

Manufacturer