Events

Retiro De Equipo (Recall) de Binding Site Human IgG4 Immage Kit

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 The Binding Site Group Ltd.

¿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
    17369
  • Fecha de inicio del evento
    2014-09-17
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • Causa
    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.
  • Acción
    Instructions for use to be updated

Device

Binding Site Human IgG4 Immage Kit

Manufacturer

The Binding Site Group Ltd