Events

Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-00520-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00520-1
  • 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
    Siemens has confirmed that there is potential for the vial volume of "in use" vista calibrators, controls or sample diluent to incorrectly revert to full volume when removed and reloaded.If vista vials revert to full volume, insufficient volume may result in the following:- calibrator vial – failed calibration- control vial – low out of range qc- sample diluent vial – auto-diluted results will flag with an above assay range error or a falsely elevated diluted result above the assay range will occur for the following methods: ctni, e2, or tsh.
  • 조치
    Siemens is providing temporary work around instructions and is in the process of implementing Vista software version 3.6. Siemens is planning to send additional communication to customers when the software is available.

Device

Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in ...
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10488224, 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division