Events

Recall of Roche Cobas modular 8000 annalyser system with cobas e602 module

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
    21165
  • Event Initiated Date
    2017-03-01
  • 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 cobas 8000 version 5.0 operator's manual, chapter 17 specifications, section list of nonstandard tubes incorrectly states that 11 to 16 mm diameter non-standard tubes may be used on the cobas e602 module. be aware that only 13 to 16 mm diameter non-standard tubes may be used on the cobas e602 module.
  • Action
    Instructions for use to be updated

Device

Roche Cobas modular 8000 annalyser system with cobas e602 module
  • Model / Serial
    Model: , Affected: version 5.0 cobas 8000 Operators Manual
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH