Events

Retiro De Equipo (Recall) de G-6-PDH Control Kits, Normal. 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 Immuno 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-00369-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-29
  • 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-00369-1
  • 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
    Following an investigation of customer complaints, the affected lot numbers have been found to have poor stability following reconstitution. it has been confirmed that the reconstituted control does not maintain the full 7 day stability when stored at 2-8degc as stated in the package insert. the control may recover within range on day 1 after reconstitution, but will fall out of range before reaching 7 days.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Acción
    Immuno is advising users to discontinue use of the affected lots, and destroy remaining stock. Affected stock will be replaced by Immuno.

Device

G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)Product Code: G6888Lot Numbers: 035, 036, 037 & 038Expiration Date: 2013-12
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA