Events

Retiro De Equipo (Recall) de BacT/ALERT BPN Culture Bottles. 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 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-2017-RN-00794-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-23
  • 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-00794-1
  • 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
    Biomérieux has become aware of a crimp defect associated with the bact/alert bpn culture bottles. an anomaly was identified during the manufacturing process that may lead to having excess material at the neck of the bottle. this material may separate from the crimp exposing a sharp edge or causing a minor cut hazard.
  • Acción
    Customers are requested to: - Confirm this letter has been distributed to and reviewed by all appropriate personnel within the organisation. - Review inventory of BacT/ALERT BPN bottles for Lot Number 1048256 and discard all affected bottles from this lot. Please store this letter with your bioMerieux instrument documentation.

Device

BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)Reference Number: 279045Lot Number: 1048256ARTG Number: 194228
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd