Events

Retiro De Equipo (Recall) de VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. 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-01333-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-06
  • 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-01333-1
  • 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 have received customer reports indicating occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327 in association with specific vitek 2 gp id lots, causing failure of the quality control (qc) testing for the vitek 2 gp id card. the expected o129r reaction for atcc 700327 strain is positive.An internal investigation determined that a positive dsor reaction that occurs early in the incubation of the card is causing an earlier end to the analysis of the card leading to an atypical negative reaction for o129r.
  • Acción
    bioMérieux is advising users to review inventory and discard any remaining stocks of the affected lots. A review of previously generated results is at the discretion of the Laboratory Manager.

Device

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)Batch/Lot Number: 2420192403Expiry: 06 June 2018Batch/Lot Number: 2420198203Expiry: 12 June 2018ARTG Number: 215320
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd