Events

Retiro De Equipo (Recall) de Biomerieux API NH

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
    15663
  • Fecha de inicio del evento
    2013-11-14
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Causa
    The manufacturer has identified a vusual defect and activity issue of the zym b reagent which is used as an additional test for revealing the results of some miniaturized tests included in api nh and api listeria. a risk analysis has been done to assess the impact of the zym b activity issue on the test results. the investigations concluded that it could lead to misidentificiation of some species with api strep, api nh, api listeria and api coryne.
  • Acción
    Product to be destroyed

Device

Biomerieux API NH
  • Modelo / Serial
    Model: 10400, Affected: Multiple
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA