Events

Retiro De Equipo (Recall) de Access hLH Calibrators used with Access 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-2012-RN-01142-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-12
  • 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-2012-RN-01142-1
  • 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 affected access hlh calibrator lots do not meet the stated expiration date claim. as a result, the quality control and patient sample results generated while using these calibrator lot numbers might be falsely elevated by as much as 13%. this can occur up to four months prior to the expiration date listed on the calibrator vial.
  • Acción
    Beckman Coulter is advising users to discontinue the use of the affected calibrator and is providing updated work around instructions to mitigate the issue. Clinicians/research scientists should be notified regarding potentially affected results at the discretion of the Laboratory Director.

Device

Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical devic...
  • Modelo / Serial
    Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD)Multiple Lot Numbers
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd