Events

Retiro De Equipo (Recall) de Grifols Australia AHG Cards. 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 Grifols Australia 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-2013-RN-00947-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-13
  • 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-2013-RN-00947-1
  • 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
    Grifols australia is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the instructions for use. the origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. this issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
  • Acción
    End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.

Device

Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Grifols Australia AHG Cards. An in vitro diagnostic medical device (IVD)Item Codes: 71300048, 71300504 & 71301008Lot Number: 13059.01Expiration Date: 10/2014ARTG Number: 178738
  • Manufacturer
    Grifols Australia Pty Ltd

Manufacturer

Grifols Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Source
    DHTGA