Events

Retiro De Equipo (Recall) de ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) 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 Siemens Ltd Diagnostics Division.

¿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-01138-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-08
  • 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-01138-1
  • 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 received complaints regarding a perceived increased rate of reactive results that do not correspond with other hbv serological markers. reagent lots ending in 044, 045 and 046 do not meet the specificity claims of 99.75% (5130/5143) with a 95% confidence interval (ci) of 99.57 to 99.87% as described in the instructions for use (ifu) for the hbct assay when used on advia centaur systems.
  • Acción
    Discontinue and discard affected lots. Affected lots will be replaced by Siemens Ltd.

Device

ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. An in vitro diagnostic medical device ...
  • Modelo / Serial
    ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. An in vitro diagnostic medical device (IVD)Siemens Material Number: 10309508Product Number: 07566733Multiple lot numbers affectedARTG Number: 93126
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA