Events

cobas 8000 core unit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Roche Diagnostics GmbH 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
    21713
  • 사례 시작날짜
    2017-07-25
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Roche Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • 원인
    A software issue has been identified, which in rare cases resets the system configuration of the control unit software to "default"., the issue may occur during initialisation of the system setting information database. if a reading failure occurs any of the following symptoms can be identified:, 1. the date and time in the status line on screen is not displayed., 2. the information about the "analytical unit" (au) is not displayed in the data review screen - but is displayed in test review., 3. the year/month/date/time of the printout preview on the history screen is not displayed., 4. cu settings under utility-system are set to "default".
  • 조치
    Manufacturer to issue advice regarding use

Device

cobas 8000 core unit
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Software versions 05-02, 06-02 and 06-03
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH