Events

Retiro De Equipo (Recall) de Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter 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-00724-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-07
  • 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-00724-1
  • 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
    The access thyroglobulin reagent pack lots may generate falsely elevated results at concentrations <10 ng/ml. the estimated maximum magnitude of the potential error in the affected range is a shift of up to 0.36 ng/ml high at concentrations <10 ng/ml. acceptable total imprecision was observed at values of 10 ng/ml and higher.
  • Acción
    Beckman Coulter is requesting their customers to discard all Access Thyroglobulin reagent pack from the affected lots. Retesting should be carried out at the discretion of the laboratory director. This action has been closed-out on 26/08/2016.

Device

Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Ac...
  • Modelo / Serial
    Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD)For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.Product REF - 33860Lot Number:430969 431990 434727 522896 523251
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd