Events

Retiro De Equipo (Recall) de ADVIA Centaur PSA 100 test kit and 500 test kit. 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-2016-RN-00005-2
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-01-06
  • 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-2016-RN-00005-2
  • 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 has confirmed that the lots ending in 263 and above are not meeting the current high-dose hook effect expectation that patient samples with total psa levels as high as 10,000 ng/ml (µg/l) will assay greater than 100 ng/ml (µg/l) as indicated in the instructions for use (ifu).Based on siemens’ internal testing, samples with total psa concentrations between 4200 ng/ml (µg/l) and 8400 ng/ml (µg/l) do not assay >100 ng/ml (µg/l) but instead result in falsely depressed concentrations of approximately 50 ng/ml (µg/l) to 94 ng/ml (µg/l).The disease state would be clinically apparent in a patient with a psa level >4200 ng/ml (ìg/l). a review of previously generated results due to this issue is at the discretion of the laboratory.
  • Acción
    The sponsor is advising users to review the customer letter. Customers can continue to use this product with the understanding that patient samples with total PSA levels between 4200 and 8400 ng/mL (µg/L) will result in falsely depressed results between 50 and 94 ng/mL (µg/L). Customers may opt to change their dilution point based on their patient population and individual laboratory needs.

Device

ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)Siemens Material Numbers: 10310292 and 10310293Lot Numbers: All lots ending in 263 and aboveARTG Number: 175243
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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