Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    An internal investigation has confirmed that oxoid antimicrobial susceptibility testing disc qd15 quinupristin / dalfopristin may contain a small number of discs that produce variable results. not all of the lot is affected, however, it has been identified that some discs may produce larger than expected or unexpected zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
  • Acción
    The sponsor is advising users to inspect stock and quarantine the affected units. Results issued with the above batch should be reviewed against case histories, other results and other relevant individual data.