Events

Recall of VIDAS® and mini VIDAS® systems

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
    22618
  • Event Initiated Date
    2018-02-15
  • 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 identified pump clogging and displacement of the color-coded spr® label (dot). these pump clogging and dot displacement could contribute to erroneous results for any assay performed on the vidas® and mini vidas® system due to a decrease of pipetted volume.
  • Action
    Manufacturer to issue advice regarding use

Device

VIDAS® and mini VIDAS® systems
  • Model / Serial
    Model: , Affected: Ref codes Mimi Vidas 99174, 99733, 99734, 99737, 99739,410416, W1421 and Vidas 93296, 93297, 99011, 99444, 99735,W3205,410417
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA