Events

Retiro De Equipo (Recall) de Access BR Monitor used with the Access family of Immunoassay systems. 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 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-2017-RN-01360-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-25
  • 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-2017-RN-01360-1
  • 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
    In april 2017 (tga reference rc-2017-rn-00500-1) beckman coulter advised customers of issues with the access br monitor relating to results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).As a follow up, beckman coulter will update the access br monitor instructions for use (ifu). the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.
  • Acción
    Beckman Coulter is advising users of the updated 95th percentile upper reference limit (URL) value for a healthy population, which is 23.5 U/mL. Beckman Coulter is recommending that users review the contents of this letter with the Laboratory Medical Director. This URL change may mean that some patient test results should be reassessed depending upon how the URL is established by the laboratory.

Device

Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medi...
  • Modelo / Serial
    Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medical device (IVD)Reference Number: 387620Lot Numbers:623913 (exp 31 May 2017)625701 (exp 30 Aug 2017)628771 (exp 30 Sep 2017)630349 (exp 31 Jan 2018)633070 (exp 28 Feb 2018)723522 (exp 31 Mar 2018)723523 (exp 30 Apr 2018)723741 (exp 30 Jun 2018)723916 (exp 31 Jul 2018)All future lotsARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd