Events

Retiro De Equipo (Recall) de Oxoid Xpect Legionella Test Kit (R24680), 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 & New Zealand.

¿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-2013-RN-00159-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-20
  • 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-2013-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
    Investigations by the manufacturer have confirmed that cassettes within this lot of oxoid xpect legionella test kit may produce false positive results. continued use of this lot could result in the false reporting of the presence of legionella pneumophila serogroup 1 and 6 antigens in human urine samples.
  • Acción
    Thermo Fisher Scientific is requesting their customer to inspect their stock and quarantine any affected units. Upon confirmation of affected stock Thermo Fisher Scientific will provide a credit note.

Device

Oxoid Xpect Legionella Test Kit (R24680), an in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand