Events

Retiro De Equipo (Recall) de Quidel Sofia Legionella FIA. 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 Thermo Fisher Scientific 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-2015-RN-01034-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-22
  • 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-2015-RN-01034-1
  • 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
    Investigations have confirmed that certain lots of quidel sofia legionella fia may give a false positive reading in some cases some cases due to rheumatoid-like factors present in the urine of some patient specimens. revised instructions for use (ifu) are being provided which specifically references instances where these rheumatoid-like factors may be present and recommends a method for testing these particular patient samples.
  • Acción
    Thermo Fisher is providing users with a revised IFU which includes instructions on the treatment of samples when a false positive is suspected.

Device

Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Quidel Sofia Legionella FIA. An in vitro diagnostic medical device (IVD) Catalogue Number: QUI20244Lot Numbers: 100812,103284,104721,109609,110854,111447,217581,701553ARTG Number: 250592
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd