Events

Retiro De Equipo (Recall) de Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. 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 Healthcare Pty Ltd.

¿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-2018-RN-00277-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-27
  • 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-2018-RN-00277-1
  • 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 that some dimension vista diluent lots may have an incomplete slit on the septum in the cap of the vial. a diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the dimension vista system, due to a reduced volume of diluent being pipetted from the vial.There have been no injuries reported as a result of this issue.
  • Acción
    Siemens is advising users to inspect stock and discard any remaining stock of the affected lots. Siemens is not recommending a review of previously generated results.

Device

Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical de...
  • Modelo / Serial
    Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD) CTNI Sample DiluentCatalogue Number: KD692Siemens Material Number: 10445202Lot Number: 7BDA34Expiry Date: 01-06-2018Multi 2 Sample DiluentCatalogue Number: KD694Siemens Material Number: 10483586Lot Number: 7CDA79, 7DDA70Expiry Date: 01-09-2018, 01-11-2018ARTG Numbers: 182774 and 182222Siemens Healthcare - Troponin IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA