Events

Sysmex XN-550 Automated Haematology Analyser. 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-00485-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00485-1
  • 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
    Sysmex have found that that potentially inaccurate results could occur from improper mixing of a sample on the sysmex xn-550 automated haematology analyser with the following conditions:- the sample tube setup is for rbt micro collection tube or sarstedt sample tube, and- the xn-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.If there is a sample tube located in the sample tube holder at this time, it will not be processed until the operator accepts the error message. sedimentation of the blood sample could occur during this time between error display and acceptance of the error, leading to potentially inaccurate results because the sample is processed without additional mixing. sysmex has found this issue is due to a software bug.
  • 조치
    Roche is advising users that this issue will be resolved in a software update that is expected to be released in May 2017 and will be installed by Roche personnel. Roche will contact users to arrange for the installation. In the interim, laboratories that use RBT micro collection tubes and/or Sarstedt sample tubes are advised to follow the directions provided in the customer letter when an error message related to a host communication and/or TCP/IP connection occurs.

Device

Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)ARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited