Events

Retiro De Equipo (Recall) de Biomerieux Etest Ertapenem foam and Single Blister Packs

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
    16265
  • Fecha de inicio del evento
    2014-02-20
  • 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
    Biomérieux has identified that the affected etest strips do not give the correct minimum inhibitory concentration (mic) for some quality control strains, with the mic results out of range (high) according to the mic specification described in the quality control procedure., the mic results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the mic.
  • Acción
    Product to be destroyed

Device

Biomerieux Etest Ertapenem foam and Single Blister Packs
  • Modelo / Serial
    Model: Reference Numbers: 531618, 531640, 415332, Affected: Lots: 1002054430, 1000853690 & 1001960650, 1002110560 & 1002389880
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA