Events

Recall of Roche cobas c502 c-pack MULTI

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
    16404
  • Event Initiated Date
    2014-03-24
  • 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 advises there is potential for erroneous results to be generated by the cobas c502 as a consequence of incorrect cassette filling. due to an in-house labelling software limitation, the icvc 'on' settings are not correctly encoded in the rec files released to the market so far, and in consequence no icvc is being performed on cobas c502 for tests requiring manual reagent handling.
  • Action
    Software to be upgraded

Device

Roche cobas c502 c-pack MULTI

Manufacturer

manufacturer #1479