Events

Retiro De Equipo (Recall) de VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomerieux Australia 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-2013-RN-00168-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-22
  • 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-2013-RN-00168-1
  • 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
    Under specific conditions, vitek 2 60/xl and vitek 2 compact pc systems connected to a laboratory information system have the potential to link a test result to an incorrect patient record. the four conditions required to potentially cause an occurrence of this issue are:- patient demographics option is enabled- patient demographics are not associated with the isolate- user does not resolve qualified isolates- laboratory re-uses lab ids (accession numbers) prior to qualified isolates being resolved.
  • Acción
    Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013.

Device

VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacteri...
  • Modelo / Serial
    VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system) Used with the following PC models:Hewlett-Packard rp5700, Catalogue Number W0452Hewlett-Packard rp5800 XPE, Catalogue Number 413642Hewlett-Packard WES7, Catalogue Number 413862Hewlett-Packard dc7800, Catalogue Number W0449Hewlett-Packard dc7700 8-port, Catalogue Number W0447Hewlett-Packard dc7100 8-port, Catalogue Number W0441
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd