Events

Rappel de cobas 8000 core unit

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Roche Diagnostics GmbH.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    21713
  • Date de mise en oeuvre de l'événement
    2017-07-25
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Cause
    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".
  • Action
    Manufacturer to issue advice regarding use

Device

cobas 8000 core unit
  • Modèle / numéro de série
    Model: , Affected: Software versions 05-02, 06-02 and 06-03
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH