Events

Retiro De Equipo (Recall) de Dimension Vista RF Flex Reagent Cartridge (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-00750-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-23
  • 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-00750-1
  • 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 has confirmed an increase in the rate of abnormal assay errors (e143: abnormal assay) with the dimension vista rf flex reagent cartridge lot 12283ma. the errors can occur on calibration, qc and/or patient sample. any result produced with the abnormal assay error is deemed non-reportable as stated in the dimension vista operator's guide (section 5-49).
  • Acción
    Siemens Healthcare is advising users to discontinue use and discard remaining inventory.

Device

Dimension Vista RF Flex Reagent Cartridge (an in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dimension Vista RF Flex Reagent Cartridge (an in vitro diagnostic medical device (IVD)Catalogue Number: K7068Lot Number: 12283MAARTG Number: 178155
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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