Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). 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-00393-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-05
  • 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-00393-1
  • 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
    Internal investigations by oxoid limited have identified variability in concentration of certain lots of timetin tim85. active compound degradation over the shelf life may result in lower than specified concentration leading to out of specification performance results (small zone size).Continued use of this product could result in delayed or false resistance reporting.
  • Acción
    Thermo Fisher Scientific is advising users to inspect stock and remove any remaining stocks of the affected product from use. Please complete the reply form and return in order for a credit note to be issued.

Device

Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). A...
  • Modelo / Serial
    Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD).Product Code: CT0449BAll lots affectedARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand