Events

cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). 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-2012-RN-01299-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01299-1
  • 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
    There is a potential issue regarding the date of birth demographic in it 1000 when a change in timezone is made on the it 1000 server. if the user enters a patient date of birth manually in "results & results>single patient edit", the cobas it 1000 application may save an earlier date instead, the most common example being that the date of birth is listed as the day prior. for example; a patient date of birth is entered as 01-nov-1931 and is saved as 31-oct-1931.
  • 조치
    Roche is providing work around instructions for users to implement.

Device

cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software)...
  • 모델명 / 제조번호(시리얼번호)
    cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). An in vitro diagnostic medical device (IVD)ARTG Number: 174914
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited