Events

Retiro De Equipo (Recall) de Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL)

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-2015-RN-00368-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-28
  • 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-2015-RN-00368-1
  • 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 has detected a situation with bcs / bcs xp analysers regarding factor ix assay determinations for haemophilia b patients. internal investigations showed discrepancies for siemens bcs / bcs xp within dilution studies. siemens has confirmed that samples at the lower measurement range were found elevated on the bcs/bcs xp system. patient results in the lower measuring range may be misclassified within a higher factor ix level. patients that have been evaluated for hereditary factor ix deficiency disease for the first time may have to be re-evaluated.A falsely elevated factor ix level may lead to a delay in diagnosis of a bleeding disorder related to factor ix deficiency. this may lead to additional diagnostic testing and delayed prophylactic therapy.
  • Acción
    Siemens has provided a workaround for users along with a technical support contact number, whilst a permanent fix is being developed. Customers are advised to follow their laboratory protocol regarding the need for review of previously reported patient results. This action has been closed-out on 01/03/2018.

Device

Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Ac...
  • Modelo / Serial
    Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL)Siemens Material Numbers (SMN): BCS: 10454742, 10454729; BCS XP: 10461894, 10470625ARTG Number: 178116An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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