Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. 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-01115-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-24
  • 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-01115-1
  • 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
    Investigation by oxoid has identified that a single lot of oxoid antimicrobial susceptibility testing disc ceftazidime may contain discs with a reduced concentration of antibiotic, which may impact on performance. testing with pseudomonas aeruginosa atcc 27853 (eucast quality control organism) returned lower than specified zones of inhibition. continued use of this lot could result in quality control failures, delayed results or incorrect results reporting (false resistance).
  • Acción
    Thermo Fisher is advising users 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. This action has been closed-out on 11/05/2017.

Device

Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. An in vitro diagnostic medic...
  • Modelo / Serial
    Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)Product Code: CT1629BLot Number: 1426486ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand