Events

Retiro De Equipo (Recall) de VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies Pty Ltd.

¿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-00086-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-10
  • 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-00086-1
  • 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
    Possible visible and/or sub-visible microbial contamination of sample diluent was identified following a customer notification. internal testing has shown filtration of sample diluent using a 0.2 micron filter does not cause any significant change in performance of the diluent and therefore may be employed by the customer.
  • Acción
    Internal testing by The Binding Site has shown that filtration of the sample diluent using a 0.2 micron filter does not cause any significant change in the performance of the diluent and therefore may be employed by the customer to remove the physical matter that may be present. It is strongly recommended that the filter and any alternative receptacles used are both as clean as possible in order to prevent any further potential for contamination of the product. This action has been closed-out on 03/08/2016.

Device

VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016

Manufacturer

In Vitro Technologies Pty Ltd