Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. 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-2015-RN-01097-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-10
  • 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-01097-1
  • 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
    An internal technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that certain lots of oxoid antimicrobial susceptibility testing disc cefoxitin may contain discs that have insufficient concentration of antibiotic. it has been identified that the low concentration may impact on the performance of the disc against escherichia coli and neisseria gonorrhoeae quality control organisms resulting in lower than expected zones of inhibition. performance with the staphylococcus aureus qc organism is currently within specification.Continued use of this lot could result in quality control failures, delayed results or incorrect results reporting.
  • Acción
    End users are requested 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 22/08/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. An in vitro diagnostic medical device ...
  • Modelo / Serial
    Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. An in vitro diagnostic medical device (IVD) Product Code: FOX30 CT0119BLot Numbers: 1689092 & 1689093093ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand