Retiro De Equipo (Recall) de ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; 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-00765-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-30
  • 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 a decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems. this under-recovery has been observed in plasma samples with high bnp and tsh-3 values that require dilution to achieve results within the reportable range on the advia centaur and advia centaur xp systems.
  • Acción
    Siemens is providing work around instructions for users to follow.

Device

  • Modelo / Serial
    ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; An in vitro diagnostic medical device (IVD)REF: 2 pack - 07293184 (110312) and 6 pack - 0790714 (110313)Multiple Lot Numbers Supplied with:ADVIA Centaur BNP kitREF: 02816634 and 02816138ADVIA Centaur TSH-3 Ultra kitREF: 06491080 and 06491072
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA