Events

Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-2017-RN-00828-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00828-1
  • 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
    Roche diagnostics australia has been informed by sysmex asia pacific that potentially inaccurate wbc results could occur on the xn-l series analysers.It was reported that the wbc results could be false low when the following steps are performed:- the manual mode is selected- whole blood mode (diluent or body fluid mode) is changed to low wbc mode- measurement information is set with manual dialog and then closed by ok- no measurement obtained with low wbc mode and then the mode is changed to another measurement mode- the next measurement wbc result becomes half of the correct wbc valuethis issue may lead to incorrect diagnosis or treatment but this risk is mitigated when the clinical decision is made by considering the previous results, patient conditions and other test results. one complaint worldwide has been received (from japan) relating to this issue. no such complaints to date have been received in australia.
  • 조치
    Roche will be contacting users to arrange the installation of a software upgrade to version 00-16A as a permanent fix. For previously affected results, users should discuss with their Medical Director whether a look-back is required.

Device

Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic...
  • 모델명 / 제조번호(시리얼번호)
    Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)Analysers with s/w version 00-13 and above that have product licence for Low WBC modeARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited