Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

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-2015-RN-00094-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-10
  • 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-2015-RN-00094-1
  • 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
    Cartridges within the affected batch may contain some discs with a degraded or insufficient level of ingredient (clavulanic acid). a technical investigation confirmed that discs within this lot may have insufficient concentration of ticarcillin/clavulanic acid potentially resulting in below specification zones of inhibition. continued use of this lot could result in a false indication of resistance to timentin.
  • Acción
    Customers are advised to inspect stock on hand and and to remove from further use all affected units. On receipt of the Reply Form ThermoFisher will issue a credit note. This action has been closed-out on 24/05/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand