Events

Recall of Simtomax In vitro screening test for Coeliac Disease

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Augurix 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
    19941
  • Event Initiated Date
    2016-03-29
  • 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: Smith Biomed (NZ) Ltd, P O Box 8108, Level 2, 44B Victoria Road, New Plymouth
  • Reason
    Due to an issue with over labelling of the simtomax coeliac disease test the expiry dates may not correctly match the stock supplied. the efficacy of the test is not in question however stock received may not necessarily reflect the correct batch that should have been received. the tests are not past their expiry date and the tests that consumers have taken to date had not expired and the efficacy of the test is not in question.
  • Action
    Product to be returned to supplier

Device

Simtomax In vitro screening test for Coeliac Disease
  • Model / Serial
    Model: , Affected: Batches: 192065, 195218, 195220 and 195378
  • Manufacturer
    Augurix SA

Manufacturer

Augurix SA
  • Manufacturer Parent Company (2017)
    Augurix SA
  • Source
    NZMMDSA