Retiro De Equipo (Recall) de Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. 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-2017-RN-00347-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-14
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    There has been confirmation that in isolated cases when enzymatic creatinine (ecrea) is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ecrea result. whilst it is understood that users routinely run quality control (qc) after system maintenance, it is particularly important to run ecrea qc after the probe test to identify a potentially elevated ecrea result. (please note that this information applies only to laboratories processing enzymatic creatinine (ecrea: enzymatic creatinine cat no. k1270a, smn 10700444) after the implementation of the automated acid clean (acln) maintenance routine).
  • Acción
    Siemens is recommending affected users to adhere to the following steps: 1) replace the appropriate reagent probe (only if the ECREA reagent probe has not been replaced since the activation of ACLN) 2) process QC which includes ECREA immediately after routinely scheduled Off Peak Activities including Probe Test; and 3) contact Siemens Customer Care Centre IF, after replacement of reagent probe, users experience elevated ECREA QC results directly after Off Peak Activities which includes the Probe Test or after manually processing the Probe Test.

Device

  • Modelo / Serial
    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD).Dimension Vista 500 Intelligent Lab System Siemens Material Number (SMN) 10488224Dimension Vista 1500 Intelligent Lab SystemSiemens Material Number (SMN) 10444802ARTG number: 174699
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA