Events

ADVIA Chemistry Systems. 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-01158-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01158-1
  • 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
    When the system switches from the primary reagent pack to the back-up reagent pack, the software may result in the auto-calibration or qc to utilise the incorrect values for the blank and standard. the systems should not pass calibration and qc, however, the software version affected may allow the system to pass calibration and qc. this may result in a shift in patient results which can be observed through patient trending.
  • 조치
    A software upgrade will be implemented for ADVIA systems 1800 and 2400 as a permanent fix. As the ADVIA 1650 is planned to be made obsolete effective March 2014 the software update has not been designed for this device. Siemens is providing users with work around instructions to follow as an interim measure. A review of previously generated results is at the discretion of the laboratory director. Thia action has been closed on 28/01/2016

Device

ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)ADVIA 1650Software versions: V3.52, V4.01ADVIA 1800Software version: V2.01ADVIA 2400Software version: V4.01Siemens Reference Number: CHSW 13-03ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division