Events

Retiro De Equipo (Recall) de Human IgG4 Kit Immage KitProduct code: LK009.IM

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies Pty 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
    RC-2014-RN-00991-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00991-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    As a result of customer complaints, the manufacturer (the binding site) identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
  • Acción
    In Vitro Technologies is advising that care must be taken when interpreting results from patients suspected of suffering from IgG4-RSD and recommend that for any patient where the IgG4 concentration does not concur with their clinical history or other test results, the sample should be re-assayed at different dilutions to identify if any antigen excess is occurring. In addition, the IgG4 result should be equated to the total IgG result and any significant discrepancies investigated. The instructions for use have been updated to include these recommendations. This action has been closed-out on 03/02/2017.

Device

Human IgG4 Kit Immage KitProduct code: LK009.IM

Manufacturer

In Vitro Technologies Pty Ltd