Events

Retiro De Equipo (Recall) de VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomerieux Australia 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-2016-RN-00159-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-10
  • 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-2016-RN-00159-1
  • 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
    Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, biomérieux performed an investigation concluding that the performance of vidas toxo igm kit while using with heat inactivated sera (56°c for 30 minutes) is not in accordance with the performance characteristics as stated in the ifu. the investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results. in remote cases this may result in a delayed diagnosis and treatment for immunocompromised patients, organ transplanted patients, foetuses (in the case of gestational infection) and neonates.
  • Acción
    Biomerieux is advising users to not use heat inactivate sera before testing. Any concerns regarding previously generated results should be discussed with the Laboratory Director.

Device

VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic...
  • Modelo / Serial
    VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)Reference Number: 30202Multiple Lot Numbers affectedARTG Number: 209618
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd