Events

Retiro De Equipo (Recall) de BFT II Analyser(Coagulation studies analyser)

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-01174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-13
  • 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-2013-RN-01174-1
  • 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
    Standard human plasma (shp, ref orkl) pre-dilution ratios given in the reference guides of the bft ii analyser do not correspond to the standard dilution procedure for endogenous coagulation factor determination. the incorrect dilution ratio stated in the reference guides is limited to the lowest calibration point.
  • Acción
    Siemens are advising their customers to discontinue use of the affected application sheet for the calculation of endogenous coagulation factors from the BFT II Reference Guide Versions 3.00, 3.01 and 3.02. A revised Reference Guide will be provided. A look back at previous results is not recommended however this requirement should be determined at the discretion of the laboratory.

Device

BFT II Analyser(Coagulation studies analyser)
  • Modelo / Serial
    BFT II Analyser(Coagulation studies analyser)Catalogue Number: OVKF03Siemens Material Number: SMN 10458677ARTG Number: 178116 An 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