Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing discs for Ertapenem (ETP10). 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-00269-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-25
  • 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-00269-1
  • 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 have confirmed that cartridges within this batch may contain individual discs with insufficient amount of antibiotic. continued use of this lot could result in false indication of resistance to ertapenem.
  • Acción
    End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director.

Device

Oxoid Antimicrobial Susceptibility Testing discs for Ertapenem (ETP10). An in vitro diagnostic me...

Manufacturer

Thermo Fisher Scientific Australia & New Zealand