Events

Retiro De Equipo (Recall) de TM0268 GC Sugar Set. 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-01157-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-06
  • 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-2017-RN-01157-1
  • 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 received an internal technical investigation confirming that a specific lot of tm0268 gc sugar set may provide atypical performance when used with some strains of neisseria species. false negative results may be seen with the glucose reaction with some strains. continued use of this lot may result in incorrect results reporting or a delay to results reporting due to additional testing requirements.
  • Acción
    1. Inspect and remove from further use all units from the affected batch number, then complete the supplied Facsimile Reply Form and return for a credit note to be issued.

Device

TM0268 GC Sugar Set. An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand