Events

Recall of bioMerieux R-Gene BK Virus kit.

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

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
    21146
  • Event Initiated Date
    2017-02-24
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    Following a customer complaint and an internal investigation, it has been confirmed that when testing weak viral load samples in conjunction with bk virus r-gene kit on smartcycler 2.0 platform, negative results may be obtained.
  • Action
    Manufacturer to issue advice regarding use

Device

bioMerieux R-Gene BK Virus kit.
  • Model / Serial
    Model: , Affected: bioMerieux R-Gene BK Virus kit on SmartCycler 2.0 platform
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA