Events

Retiro De Equipo (Recall) de Glucose GLUC-PAP. 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 Randox 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-2016-RN-01642-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-23
  • 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-01642-1
  • 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
    Randox confirms a transcription error when quoting the concentration in g/l for glucose standard lot 2082gl. the correct value should state 0.98g/l.The risk to health when this issue occurs is the potential for reporting incorrect elevated glucose results. however this is highly unlikely as quality control results would also be elevated by a factor of ten.
  • Acción
    Randox is requesting users; 1. Replace the kit IFU with the correct revision as attached to the customer letter; 2. Discuss the contents of the notice with your Medical Director; and 3. Complete and return the vigilance response form provided.

Device

Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).Catalogue Number: GL1021GTIN: 05055273203165Batch/Lot Number: 385671Expiry Date: 28th Jan 2019ARTG Number: 199617
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA