Events

Recall of Mesa EZTest Biological Indicators

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

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
    14837
  • Event Initiated Date
    2013-06-18
  • 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: W M Bamford & Co Ltd, 12 Victoria Street, LOWER HUTT
  • Reason
    The manufacturer, mesa, recently determined that the read out time is not in specification with the label claims on these lots. there is potential for delayed or incomplete colour change (false fail) at the indicated incubation time of 10 hours.
  • Action
    Product to be returned to supplier

Device

Mesa EZTest Biological Indicators
  • Model / Serial
    Model: Models: EZS/6 & EZS5/25, Affected: Lots: S-445 & S-447
  • Manufacturer
    Altrax Group Ltd

Manufacturer

Altrax Group Ltd