Events

Retiro De Equipo (Recall) de Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

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-01024-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-23
  • 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-01024-1
  • 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
    A technical investigation has confirmed that the affected lot contains insufficient concentration of penicillin. continued use of this product could result in the incorrect reporting of minimum inhibitory concentration against penicillin.
  • Acción
    Thermo Fisher is advising users to inspect stocks and remove from use any remaining units of the affected lot number. Affected stock can be returned or destroyed for credit. Results issued with the affected lot number should be reviewed against case histories, other results and other relevant individual data. This action has been closed-out on 25/08/2016.

Device

Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml

Manufacturer

Thermo Fisher Scientific Australia & New Zealand