Retiro De Equipo (Recall) de Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. 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 Bio-Rad Laboratories 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-2012-RN-01295-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-24
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    There is a risk of false negative results being reported in urine samples; the concentration of adrenaline/epinephrine may decrease when analysis time is more than 8 hours. this occurs when the samples are subsequently adjusted to ph 5 to 7 as described in the instructions for use for very acidic samples or samples with low 24-volumes.
  • Acción
    The sponsor is providing an update to the Instructions for Use (IFU).

Device

  • Modelo / Serial
    Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagnostic medical device (IVD)Catalogue Number: 1955700
  • Manufacturer

Manufacturer