Events

Retiro De Equipo (Recall) de Dimension Vista Systems - Theophylline (THEO) 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-2014-RN-01206-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-11-13
  • 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-2014-RN-01206-1
  • 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 abnormal reaction flags (e145: abnormal reaction) with dimension vista theophylline (theo) flex reagent cartridge lot 14148ac. the abnormal reaction flags can occur on calibration, qc and/or patient samples. any result with an abnormal reaction flag is deemed non-reportable as described in the dimension vista operator’s guide.The potential for an abnormal reaction flagged result when using the affected lots would prevent reporting theophylline values. the frequency of obtaining abnormal reaction flags as a result of this issue is variable among customer sites ranging from 0 flags to 100% of results flagged.
  • Acción
    Siemens is requesting their customers to discontinue use and discard any remaining inventory of Dimension Vista THEO lot 14148AC. Siemens will replace any unused inventory of the affected lot at no charge. This action has been closed-out on 02/03/2016.

Device

Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medi...
  • Modelo / Serial
    Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD).Catalogue Number: K4071Lot Number: 14148ACARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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