Events

Recall of Roche IgE II assay

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    19021
  • Event Initiated Date
    2015-08-25
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Internal investigations have found there is no direct binding competition between xolair® and the, anti-ige antibodies of the ige ii assay. however, xolair® forms soluble complexes with ige antibodies, and this leads to reduced recovery of the ige ii assay., this effect can only be seen when creating serial dilutions of a sample and checking the linearity of these different dilutions. it will not necessarily be detected by performing a single dilution of the sample.
  • Action
    Instructions for use to be updated

Device

Roche IgE II assay
  • Model / Serial
    Model: 4827031190, Affected: All lots in the market
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479