Events

Retiro De Equipo (Recall) de Roche IgE II assay

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    19021
  • Fecha de inicio del evento
    2015-08-25
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    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.
  • Acción
    Instructions for use to be updated

Device

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

Manufacturer

manufacturer #1479