Events

Retiro De Equipo (Recall) de MIA FORA NGS Software v3.27.0. 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 Diagnostic Solutions 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-01303-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-24
  • 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-2017-RN-01303-1
  • 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
    Diagnostic solutions has been advised that as a result of a complaint investigation, it has been determined that mia fora ngs software is impacted by an error in the v3.27.0 reference database update. customers testing all 11 hla genes, 9 hla genes and 6 hla genes with the mia fora ngs flex hla kits are impacted. reference sequences specific to hla-drb6 and other non-target reference sequences were inadvertently omitted from the v3.27.0 reference database and as a result, this may impact the accuracy of the automatic calls and the need to manually review results. this is most frequently observed with hla-dpb1 results.
  • Acción
    Diagnostic Solutions will be in contact with users when a software update is available to include the revised reference database. In the interim, users may utilise either of the following options: 1. Continue use of the v3.27.0 reference database and manually inspect all DPB1 results pending availability of the corrected database; or 2. Revert to v3.24.0. Guidance on how to do this may be provided upon request by Immucor. Note: after reverting to v3.24.0 users must reanalyse projects previously analysed with the v3.27.0 reference database using the v3.24.0 reference database.

Device

MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd