Events

Retiro De Equipo (Recall) de BK Virus R-gene

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
    20574
  • Fecha de inicio del evento
    2016-08-29
  • 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
    Following a customer compaint about difficulties to interpret low viral load in whole blood samples, an investigation showed that the sensitivity of the bk virus r-gene® claimed in the ifu for whole blood was not confirmed., the issue is only impacting whole blood samples with a low viral load, where amplification leads to creeping/flat curves difficult to interpret., this issue has no impact on negative results or on high positive samples, as the amplification curves are well identified.
  • Acción
    Manufacturer to issue advice regarding use

Device

BK Virus R-gene
  • Modelo / Serial
    Model: 69-013B, Affected: Lot numbers: 1003909940 1004754140 and 1004764070
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA