Events

Retiro De Equipo (Recall) de ChromID Strepto B agar (Used for screening of S. agalactiae carriage in pregnant women and potential infections in newborns). 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-2012-RN-01049-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-16
  • 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-2012-RN-01049-1
  • 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
    The investigations performed by biomerieux quality control laboratory after receiving customer complaints have confirmed a sensitivity issue for the affected batch. biomerieux cannot guarantee the characteristic colouration of the streptococcus b colonies at 24 hours and 48 hours of incubation.
  • Acción
    Discontinue use and discard affected stock. Biomerieux Australia will provide a credit note or replace the affected lots.

Device

ChromID Strepto B agar (Used for screening of S. agalactiae carriage in pregnant women and potent...
  • Modelo / Serial
    ChromID Strepto B agar (Used for screening of S. agalactiae carriage in pregnant women and potential infections in newborns). An in-vitro diagnostic medical device (IVD)Batch Number: 1001508710Reference Number: 43461
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd