Events

Retiro De Equipo (Recall) de ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)

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-00878-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-08
  • 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-00878-1
  • 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 received complaints of failed calibrations on the advia centaur® cp system when using bnp kit lots ending in 172. siemens has confirmed that the failed calibration is due to an error on the advia centaur cp master curve card. the master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the advia centaur cp. an invalid calibration status will prevent bnp results from being generated and may delay the time to result for bnp. if the calibration is successful, the results will be valid and there is no risk to health.
  • Acción
    Siemens is advising that if a successful calibration is achieved with BNP kit lots ending in 172 and quality control results are in range, you can continue to report patient results. If unable to obtain a successful calibration on the ADVIA Centaur CP with BNP kit lots ending in 172, please switch to an alternate lot of BNP. This action has been closed-out on 31/08/2016.

Device

ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)
  • Modelo / Serial
    ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)Siemens Material Numbers (SMN): 10309044 and 10309045 Lot Numbers: lots ending in 172 (Expiration date: 17 April 2015)ARTG Number: 175075
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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