Retiro De Equipo (Recall) de BioMerieux Vitek 2 System/ Vitek 2 Compact System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Causa
    Under specific conditions the vitek 2 and vitek 2 compact pc systems connected to a laboratory information system (lis) have the potertial to link a test result to an incorrect patient record., the four coditions required to potentially cause an occurence of this issue are:, patient demographics option is enabled, pateint 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
    Instructions for use to be updated


  • Modelo / Serial
    Model: W0452,413642, 413862, W0449, W0447, W0441, W0438, 410615, 413861, 413411 and 27685., Affected:
  • Manufacturer