Events

Recall of cobas 8000 core unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Roche Diagnostics GmbH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    21713
  • Event Initiated Date
    2017-07-25
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Roche Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Reason
    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
  • Model / Serial
    Model: , Affected: Software versions 05-02, 06-02 and 06-03
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH