Events

Retiro De Equipo (Recall) de Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (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-2014-RN-00135-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-06
  • 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-00135-1
  • 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 dr0802 oxoid legionella penumophila 2-14 reagent, lot 1265366 may return false negative tests. continued use of this lot may result in a delay to the correct serogroup characterisation of legionella isolates.
  • Acción
    Thermo Fisher Scientific is advising users to inspect stock and remove all affected lots from use. Thermo Fisher is advising that the requirement for review of patient results should be determined by the Laboratory Director.

Device

Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in v...
  • Modelo / Serial
    Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))Oxoid Legionella Latex Test (DR0800M)Lot Numbers: 1314413 and 1301907Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)Lot Number: 1265362
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand