Events

Retiro De Equipo (Recall) de TBS VaccZyme Anti-Haemophilus Influenzae B

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 The Binding Site Group 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
    18118
  • Fecha de inicio del evento
    2015-02-19
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • Causa
    The manufacturer advises that the type iii sample diluents of batches 341738 and 347336 provided in the above kit (lot numbers 341492 and 347294 respectively) may contain microbial growth. the identified contaminant is not present in all diluent vials but has been identified in some, in the form of either white or black matter of an organic appearance.
  • Acción
    Manufacturer to issue advice regarding use

Device

TBS VaccZyme Anti-Haemophilus Influenzae B

Manufacturer

The Binding Site Group Ltd