Events

Recall of Roche Cobas c

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
    21213
  • Event Initiated Date
    2017-03-14
  • 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 Products (NZ) Ltd, 98 Carlton Gore Road, Newmarket, Auckland 1023
  • Reason
    In very rare cases where the disturbance of the sample liquid level detection (lld) occurs, the affected sample probe may dip into the sample material deeper than intended, the affected sample probe may be not washed adequately. this may lead to carryover.
  • Action
    Product to be exchanged

Device

Roche Cobas c
  • Model / Serial
    Model: , Affected: Cobas c311: Catalogue No. 05899427001, cobas c501, c502: Catalogue No. 04547241001, cobas c702, cobas 8000 ISE: Catalogue No. 04945794001
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH