Events

Retiro De Equipo (Recall) de Various Microgenics Application Sheets

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 Microgenics Corporation.

¿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
    21578
  • Fecha de inicio del evento
    2017-06-28
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Causa
    During an internal assessment, it was found that certain application sheets provided by thermo fisher new zealand for expanded use of some assays on analyzers that are not listed in the assay instructions for use are inadequate. specifically, the validation data included in the application sheets for the expanded use of these assays, is inadequate and will not be included in future application sheets. in addition, statements have been added to the application sheets that explain that the parameter settings are not supplier qualified and are to be used for instrument programming guidance only, and that each assay used on a non-microgenics approved analyzer needs to be validated individually by the user.
  • Acción
    Instructions for use to be updated

Device

Various Microgenics Application Sheets
  • Modelo / Serial
    Model: , Affected: Incomplete Instructions for Use for Microgenics Application Sheets
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation