Events

Retiro De Equipo (Recall) de EZee-Nest Insert Cups used with ADVIA Centaur CP. 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-00389-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-05
  • 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-00389-1
  • 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 has identified an issue with use of the ezee-nest insert cups due to 2 inaccuracies that exist in the advia centaur cp operator’s guide, appendix d, pre-set tube types. the 1st inaccuracy refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50ul can be used; however volumes greater than 150ul cannot be used when using an ezee-nest insert cup. the 2nd inaccuracy refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. there is no impact on patient samples as a result of these issues. there is the potential for loss of aspirated sample (up to 250 ìl including the dead volume in the insert cup) & a delay in providing patient test results due to this issue.
  • Acción
    Siemens is advising users to not use EZee-Nest Insert Cups with assays that require sample volumes greater than 150µL or the Universal Cup Adapter with the EZnee-Nest insert cups in 65mm sample racks. Users should instead use the Siemens Sample cup along with the required 100mm sample rack and 100mm Siemens cup Tube Setting for assays that require sample volumes larger than 150µL.

Device

EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10309710ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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