Events

Retiro De Equipo (Recall) de ADVIA Chemistry Systems - Urea Nitrogen (UN). 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-2018-RN-00303-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-06
  • 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-2018-RN-00303-1
  • 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 confirmed that the urea nitrogen reagent kit lots 408143 and 418290 for use on advia 1800, 2400 and xpt chemistry systems are failing to perform as intended due to microbial contamination of a bulk reagent during the manufacturing process. this may demonstrate as an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.If calibration passes, there is a potential for falsely elevated patient and quality control results.Internal testing has also shown that for the affected lots, results have the potential to be falsely increased by approximately 10 mg/dl (3.57 mmol/l) across the analytical range. quality controls may not always detect the elevated results.
  • Acción
    Siemens is advising customers to discontinue use of and discard affected kit lots. A replacement for discarded units will be provided.

Device

ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD) Catalogue Number: 03040257Lot Numbers: 408143, 418290Expiry (both lots): 28/06/2018ARTG Number: 176642Siemens Healthcare - Clinical chemistry substrate IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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