Events

Recall of Biomerieux Nuclisens easyMAG System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by bioMerieux Italia S.p.A..

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
    18181
  • Event Initiated Date
    2015-03-05
  • 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
    The manufacturer has received five customers complaints regarding a breakage on the waste trap of the easymag instrument. this non conformity allows liquid leakages and air to get into vacuum circuit causing a permanent alarm condition.
  • Action
    Product to be modified

Device

Biomerieux Nuclisens easyMAG System
  • Model / Serial
    Model: Product Code: 200111, Affected: From EASYMAG02262 to EASYMAG02403, except EASYMAG02401
  • Manufacturer
    bioMerieux Italia S.p.A.

Manufacturer

bioMerieux Italia S.p.A.