Events

Recall of Chemistry Analyser 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
    21694
  • Event Initiated Date
    2017-07-18
  • 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
    A case was reported, in which an operator suffered a blood injury (cut thumb) after attempting to remove the metal cover of the ultrasonic mixer 3 (usm 3). this injury occurred during routine maintenance when the thumb screws holding usm 3 cover were being loosened to remove the usm cover and thus allow access to the waterbath and allow replacement of the cuvettes. contact between the operator's thumb and the edge of the usm cover caused this injury.
  • Action
    Manufacturer to issue advice regarding use

Device

Chemistry Analyser Module
  • Model / Serial
    Model: , Affected: cobas c501 and cobas c502 chemistry analyser modules.
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH