Events

Retiro De Equipo (Recall) de Biomerieux BacT/ALERT 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 BioMerieux Inc.

¿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
    13674
  • Fecha de inicio del evento
    2012-10-24
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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
    Bact/alert instrument software architecture is linearly designed to scan, proces and load one bottle at a time., manufacturer recently launched the new bact/alert 3d b.40.Xx firmware that contains additional features such as bottle recalculation and bottle authentication. as a result of the additional features customers with control modules containing lbc-586 cpus, distributed from 1997 through november 2007, and running b.40 firmware may exhibit a slightly slower instrument interface issue that may result in bottles being improperly loaded into the instrument.
  • Acción
    Instructions for use to be updated

Device

Biomerieux BacT/ALERT System
  • Modelo / Serial
    Model: 411814 or 411818, Affected: Firmware version B.40.xx
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc