Events

Retiro De Equipo (Recall) de FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). 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-2016-RN-01184-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-08
  • 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-01184-1
  • 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 the manufacturer that there is an issue with the stability of the calibrator in the kit. an increase of fluorescence was observed during the ageing of the calibrator and therefore a decrease in patient results.
  • Acción
    Diagnostic Solutions to advising users to inspect stock and destroy any remaining kits of the affected lots. Affected stock will be replaced with unaffected product. It is recommended that previously reported results are reviewed at the discretion of the laboratory director. This action has been closed-out on 11/05/2017.

Device

FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An ...
  • Modelo / Serial
    FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)Product Code: BM-MX005-sLot Number: LE124535Expiry: 31 Jan 2018ARTG Number: 198370
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd