Events

Recall of Roche Cobas ONLINE TDM Gentamicin

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    21032
  • Event Initiated Date
    2017-01-20
  • 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 Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    The manufacturer has become aware of the implementation of an instrument factor (if) to mitigate the increased recovery of gentamicin with the online tdm gentamicin assay. following further complaints and against initial data, the factor has been found to not correct the issue.
  • Action
    Manufacturer to issue advice regarding use

Device

Roche Cobas ONLINE TDM Gentamicin

Manufacturer

manufacturer #1479