Events

Retiro De Equipo (Recall) de RAPID Hp StAR Kit (used in the detection of H. pylori). 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-2016-RN-00620-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-10
  • 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-00620-1
  • 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
    An internal technical investigation by oxoid limited, has identified that the affected lot may give a weak false positive line with no h. pylori antigen present, making interpretation of test results more difficult than with previous batches. continued use of this lot may result in a delayed or false positive results reporting.
  • Acción
    Thermo Fisher is advising users to inspect stock and remove any remaining product of the affected lot number from use. A credit note will be issued. A review of previously generated patient results is at the discretion of the Laboratory Director. This action has been closed-out on 03/02/2017.

Device

RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand