Events

Retiro De Equipo (Recall) de EZ1 Advanced XL instrument. 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 Qiagen 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-00843-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-29
  • 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-00843-1
  • 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
    Qiagen have identified an issue regarding the power branching printed circuit board (pcb) within the ez1 advanced xl instrument. occasionally this has the potential to trigger a malfunction of the instrument heater. nucleic acid extractions processed during failure of the instrument could be compromised and extractions need to be repeated.To date, no adverse events have been reported as a result of this issue.
  • Acción
    Qiagen are advising they will replace the faulty component in all potentially affected instruments. Until devices have been corrected, users are advised to complete the following test after every run: 1. Put any EZ1 XL Card into the instrument; 2. Select “3” in the main menu to select test functions; 3. Press ”2” in the test screen to choose the “Temp” operation; 4. Set the temperature to “40.0” degrees; 5. Press “START”; then Observe the “actual” temperature which is displayed. This should rise to 40.0 C +/- 2 degrees within 2 minutes, and an “O” should be displayed next to the temperature value. In the event that the “actual” temperature does not rise to 40.0 C, an “X” continues to be displayed next to the temperature value, this indicates that the instrument is affected by this issue. In this case the nucleic acid eluate from the previous run should be rejected and the sample reprocessed. Contact technical services to arrange a replacement of the faulty component.

Device

EZ1 Advanced XL instrument. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    EZ1 Advanced XL instrument. An in vitro diagnostic medical device (IVD)Serial Numbers: L16XA1681, L173A1950 and L175A1998ARTG Number: 221971(Qiagen Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd