Events

Retiro De Equipo (Recall) de Biomerieux FB Reagent

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
    16417
  • Fecha de inicio del evento
    2014-03-27
  • 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
    During the quality control of new lot of fb reagent, a visual defect (colour issue) was observed. the first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this fb reagent. in addition, this lot of raw material has also been used for the manufacturing of several lots of fb reagent and zym b reagent using the same raw material than the fb reagent. as the involved lots of zym b reagent are included inside of api nh and api listeria kits, the both references are also impacted.
  • Acción
    Instructions for use to be updated

Device

Biomerieux FB Reagent
  • Modelo / Serial
    Model: Reference: 70562, Affected: All lots
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA