Events

Recall of Roche Cepheid LightCycler VZV Quality Kit

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

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
    17438
  • Event Initiated Date
    2014-09-29
  • 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
    Users are requested to discontinue the use and discard any remaining inventory of specific lots of the lightcycler® vzv qual kit, ce-ivd which, due to kit stability issues, can lead to invalid results. due to the stability issues, positive control (pc) and non-template control (ntc) failures may be generated. previously generated, valid results do not need to be questioned or repeated.
  • Action
    Product to be destroyed

Device

Roche Cepheid LightCycler VZV Quality Kit
  • Model / Serial
    Model: GMMI 04846788001, Affected: Lots: 70012381, 70012383, and 70012389
  • Manufacturer
    Cepheid AB

Manufacturer

Cepheid AB