Events

Recall of Binding Site Human IgG4 Immage Kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by The Binding Site 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
    17369
  • Event Initiated Date
    2014-09-17
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • Reason
    As a result of customer complaints, the manufacturer (the binding site) has identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results., as the binding site's igg4 assay was developed specifically for igg4 deficiency the assay has limited antigen excess capacity and therefore the analysis of samples from the hyper igg4 disease cohort may introduce the potential for antigen excess.
  • Action
    Instructions for use to be updated

Device

Binding Site Human IgG4 Immage Kit

Manufacturer

The Binding Site Group Ltd