Events

Retiro De Equipo (Recall) de ADVIA Chemistry Theophylline_2 Reagent

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-00831-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-27
  • 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-00831-1
  • 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 identified that the advia chemistry theophylline_2 (theo_2) reagent lot 334018 used on the advia 1200, 1800, 2400, and xpt chemistry systems may exhibit increased imprecision for commercially available tdm quality controls and patient specimens.Siemens internal investigation after one internal complaint was received confirmed that reagent lot 334018 is not in statistical alignment with the representative precision data published in the ifu and the design input requirements on the advia chemistry systems.Discordance with the clinical presentation is expected to lead to repeat testing or more frequent monitoring. there may be a delay in theophylline testing due to troubleshooting after failed qc.
  • Acción
    Siemens is advising users to discontinue use of and discard the kit lot. Siemens is recommending that a review of previously generated results is considered.

Device

ADVIA Chemistry Theophylline_2 Reagent
  • Modelo / Serial
    ADVIA Chemistry Theophylline_2 ReagentTest Code: THEO_2Catalogue Number: 10377503Lot Number: 334018Expiration Date: Sept 2017ARTG Number: 175699An 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