Events

Retiro De Equipo (Recall) de BacT/ALERT PF Plus Culture Bottle. 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-2013-RN-00913-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-08-30
  • 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-00913-1
  • 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
    Bact/alert pf plus culture bottle, lot 1033298, yielded reflectance results above the stability specification at the 9-month time frame. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
  • Acción
    Bio Merieux is requesting their customers to discontinue use of the affected batch remaining in stock. Bottles that are already inoculated or incubating should be allowed to complete their testing/incubation. All bottles flagged positive by the instrument should continue to be treated as stated in the instructions for use.

Device

BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)Catalogue Number: 410853Lot Number: 1033298Expiration Date: 16 October 2013
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd