Events

Retiro De Equipo (Recall) de ENA RELISA Single Well Screen (576 well) Kit. 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 Diagnostic Solutions 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-01194-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-07
  • 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-01194-1
  • 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
    Diagnostic solutions has been informed by immuno concepts that incorrect calibrator has been included with affected lots of the ena relisa single well screen kits. this may result in over-sensitivity and false positive patient results.
  • Acción
    Diagnostic Solutions is advising users to inspect stock and destroy any remaining kits of the affected lots. Diagnostic Solutions is recommending that a review of previously reported results is performed at the discretion of the Laboratory Director. This action has been closed-out on 25/08/2016.

Device

ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd