Events

Retiro De Equipo (Recall) de ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-00817-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-08-28
  • 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-00817-1
  • 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
    Siemens healthcare diagnostics has identified an error on the advia centaur confirmatory card that is included in the advia centaur hbsagii kit lot numbers 55825056, 56167056 and 56244056. the error causes an interpretation of ‘invalid’ and a flag of ‘conf n/a’ when the hbsagii positive control is tested with the hbsagii confirmatory (conf) assay.
  • Acción
    Siemens is advising laboratories that the affected ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT HBsAgII kit lots may only be used to generate HBsAgII screening results, however, an alternate lot or alternate method must be used for reporting confirmed results, if confirmatory testing is required. Siemens can assist laboratories in procuring unaffected stock if they rely on the HBsAgII kit for confirmatory testing. This action has been closed-out on 05/12/2016.

Device

ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs
  • Modelo / Serial
    ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – HbsAgII AssayCatalogue Number: SMN 10492138Lot Numbers: 55825056, 56167056, 56244056ARTG Number: 239120
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA