Events

Retiro De Equipo (Recall) de ADVIA Centaur Systems Progesterone Kits

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-00088-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-03
  • 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-00088-1
  • 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 a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using the affected advia centaur progesterone kit lots. the high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). on the advia centaur systems, for samples greater than 30 ng/ml (95.4 nmol/l), customers may observe an average dilution recovery between 48.3% and 105.0%. samples (both neat and diluted) with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.Progesterone values above 30 ng/ml (95.4 nmol/l) are indicative of pregnancy. the difference in neat values compared to diluted values will not change the clinical interpretation of the results. siemens advises that the severity of potential injury is negligible and the overall risk to health is negligible to non-existent. no laboratory look back is recommended.
  • Acción
    A workaround is provided to customers regarding dilution of samples for lots ending in 268 only. Technical Specialist contact number details are also provided for users as ongoing support. This action has been closed-out on 06/09/2016.

Device

ADVIA Centaur Systems Progesterone Kits
  • Modelo / Serial
    ADVIA Centaur Systems Progesterone KitsTest Code: PRGEKit Lot Numbers: Ending in 268Catalogue Numbers: 02382928 (1-pack), 01586287 (5-pack), 02177364 (5-pack Ref)Expiration Date: May 22, 2015ARTG Number: 175698
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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