Events

Retiro De Equipo (Recall) de RemelTM BactiStaph Latex Kits R21144,

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 Thermo Fisher Scientific Microbiology Basingstoke.

¿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
    22274
  • Fecha de inicio del evento
    2017-11-20
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Causa
    The manufacturer has received complaints of positive control failure which triggered a technical investigation which confirmed the positive control contained in the referenced products, bactistaph latex kits r21143/r21144, lots 104809/104807, may be non-reactive. the latex reagent in the kit performs as specified.
  • Acción
    Product to be destroyed

Device

RemelTM BactiStaph Latex Kits R21144,

Manufacturer

Thermo Fisher Scientific Microbiology Basingstoke