Events

Retiro De Equipo (Recall) de Roche Elecsys Vitamin D Assay (300 tests)

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 manufacturer #1479.

¿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
    22898
  • Fecha de inicio del evento
    2018-04-30
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    The manufacturer has been informed of a number of reports of performance issues during the implementation of the elecsys vitamin d total ii assay on modular analytics e170, cobas e601 and cobas e 602 systems, as well as rare cases on cobas e 411 and cobas e 801., the issue manifests as: the first result is elevated, either above the upper end of the measuring range (>250 nmol/l) or within the measuring range; and repeats are significantly lower.
  • Acción
    Manufacturer to issue advice regarding use

Device

Roche Elecsys Vitamin D Assay (300 tests)

Manufacturer

manufacturer #1479