Events

Retiro De Equipo (Recall) de Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. 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-2017-RN-01441-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-27
  • 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-2017-RN-01441-1
  • 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
    Thermo fisher scientific, has confirmed that shigella sonnei (phases 1& 2) agglutinating serum may fail to agglutinate within the specified minimum reaction time when tested with shigella sonnei phase 2 bacteria. continued use of these lots may result in a failure to correctly identify isolates as shigella sonnei phase 2.The products continue to correctly identify shigella sonnei phase 1 bacteria.
  • Acción
    Thermo fisher is advising users to inspect stock and remove any remaining units of the affected batches from use. A review of previously generated patient results is at the discretion of the Laboratory Manager.

Device

Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic...
  • Modelo / Serial
    Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic medical device (IVD) Product code: R30164201Lot Numbers: 1465529, 2118879, 2173683, 2161363, 2149414, 2135578, 1738564, 1957305, 1947930, 1847285ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand