Events

Retiro De Equipo (Recall) de Versant kPCR Molecular System Sample Preparation

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-00327-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-21
  • 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-00327-1
  • 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
    An issue has been identified regarding an unintended behaviour of the system's result-generation software. it has been observed that an internal control displayed a no baseline error but the assay result for that well was not reported as an invalid result. the correct software behaviour is to report the assay result as invalid result when the internal control for that well displays a no baseline error. this issue allows for the possibility that an incorrect assay result could be reported for a sample when the result should be invalid and the sample repeated. there is an extremely low risk of false negative results.
  • Acción
    Siemens is advising users to review each report for the affected Versant IVD assays to identify if there are any No Baseline errors in the IC channel of any wells. If a No Baseline error occurs for the Internal Control of any well, users must not report the assay result for that well and repeat the test. A review of previously generated results is at the discretion of the Laboratory Director.

Device

Versant kPCR Molecular System Sample Preparation
  • Modelo / Serial
    Versant kPCR Molecular System Sample PreparationAffected Assays: HIV-1 RNA 1.5, HBV DNA 1.0, HCV RNA 1.0, CT/GC DNA 1.0 Siemens Material Number (SMN): 10282928All serial numbers affectedARTG Number: 175890An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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