Events

Retiro De Equipo (Recall) de VITEK 2 Gram Positive- ID Card

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 SA.

¿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
    22243
  • Fecha de inicio del evento
    2017-11-10
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Causa
    An internal investigation has confirmed, occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc® 700327™ in association with three(3) vitek® 2 gp id, causing failure of the quality control (qc) testing for the vitek® 2 gp id card. in accordance with the vitek® 2 gp id instructions for use, the expected o129r reaction for atcc® 700327™ strain is positive. as a precaution, the manufacturer is also including in the scope of this notice all gp id card lots manufactured with the same raw materials.
  • Acción
    Product to be destroyed

Device

VITEK 2 Gram Positive- ID Card
  • Modelo / Serial
    Model: , Affected: VITEK® 2 GP ID Lots #2420192403, 2420198203
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA