Events

Retiro De Equipo (Recall) de ACE Control. 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-2014-RN-00156-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-14
  • 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-2014-RN-00156-1
  • 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
    Upon review of the qa release testing, the range calculated at the time of kit release (done per standard operating procedures) supports the control range assigned upon product release, i.E. 28-52 at 37°c. however, upon investigation of a complaint encompassing several lots of reagents, the assigned control range has been reevaluated and it was determined that the range for these lots requires an adjustment to 23-43 at 37°c.This recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Acción
    Immuno provided updated product information with the correct control ranges.

Device

ACE Control. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ACE Control. An in vitro diagnostic medical device (IVD)Product Code: A6040Lot Numbers: 042, 043 and 044ARTG Number: 203619
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA