Retiro De Equipo (Recall) de ADVIA Centaur Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays An in vitro diagnostic medical device ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP

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-2018-RN-00027-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-22
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 confirmed through internal investigation that certain assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the advia centaur platforms.
  • Acción
    Siemens is advising users to refer to the information provided in the Customer Letter to adjust biotin interference values accordingly for affected assays.

Device

  • Modelo / Serial
    ADVIA Centaur Cyclosporine, DHEA-SO4, Folate and HBc IgM AssaysAn in vitro diagnostic medical deviceADVIA CentaurADVIA Centaur XPADVIA Centaur XPTADVIA Centaur CPAll Lots of the above assays are affectedARTG Numbers 175242,175698, 175700, 239125
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA