Retiro De Equipo (Recall) de HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (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-2013-RN-00984-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-09-25
  • 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 has determined that not all distributed lots would meet the performance criteria as currently described in the instructions for use (ifu) with respect to the analytical sensitivity. siemens are updating the labelling to better reflect the observed and potential range of assay performance with respect to this parameter (i.E less than and equal to 2.0 iu/ml).
  • Acción
    Siemens is providing work around instructions for users to follow until the revised Instructions for Use (IFU) are released.

Device

  • Modelo / Serial
    HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an in vitro diagnostic medical device (IVD))Catalogue Number: 06520528Siemens Material Number: 10283020Multiple lot numbers affectedARTG Number: 205090
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA