Events

Retiro De Equipo (Recall) de ADVIA Centaur & ADVIA Centaur XP Immunoassay System (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-2014-RN-00910-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-20
  • 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-2014-RN-00910-1
  • 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 is conducting an urgent recall for product correction for the advia centaur and advia centaur xp immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the advia centaur and advia centaur xp immunoassay systems. pushing the sample racks may cause misreads of sample ids (sid) if the sample rack loading instructions are not followed exactly as described in the advia centaur or advia centaur xp operator’s guide.If a sample rack is manually pushed with a slight forward nudge to the entry position without placing it on the rack positioning guide, the barcoded tube sid can be assigned to different positions in the rack. this may lead to misreported results.
  • Acción
    Siemens Healthcare Diagnostics is advising the customers that when loading a sample rack, the user must ensure that the sample rack notch rests on the raised area of the sample entry queue and the system automatically moves the rack to the loading position. The raised guide ensures the sample rack is positioned correctly and will accurately scan each barcode as it enters the inprocess queue. Users are further advised not to push the sample racks into the system. During the next service visit, Siemens Healthcare Diagnostics service engineers will affix a label stating "Do not push sample rack" onto the system to reinforce the proper loading technique of the sample rack. This action has been closed-out on 5/08/2016.

Device

ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))

Manufacturer

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