Events

Retiro De Equipo (Recall) de Dako Beta-2-Microglobulin PET Kits. 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 Elitechgroup 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-2015-RN-00331-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-14
  • 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-2015-RN-00331-1
  • 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
    There is a stability issue with a single component of the kit, vial 1 beta-2-microglobulin immunoparticles. investigations have shown that a change in the ph value in the beta-2-microglobulin immunoparticles (vial 1) has occurred resulting in low or no signal for the 2 lowest standards in the calibration curve. the identified change in the ph value may affect the accuracy of beta-2-microglobulin values/results obtained, without any warnings from instruments. the beta-2-microglobulin values may be measured up to 20% higher for samples in the clinically elevated ranges.
  • Acción
    ELITech Group is advising users to cease use of the affected lot and discard any remaining inventory. This action has been closed-out on 18/07/2016.

Device

Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD) Product code: K0052Lot Number: 20012249ARTG number: 200116
  • Manufacturer
    Elitechgroup Australia PTY LTD

Manufacturer

Elitechgroup Australia PTY LTD