Events

Retiro De Equipo (Recall) de AllSet = Gold SSP

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 Australia Pty Ltd.

¿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
    21610
  • Fecha de inicio del evento
    2017-07-03
  • 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: Bio-Strategy Ltd, 22a William Pickering Drive, North Harbour, Albany, Auckland 0751
  • Causa
    The manufacturer is aware of the allset+ gold ssp kits. the primers pm074d and c15-02a should be negative for the following alleles: :, b*07:219, b*57:02:01, , b*57:02:02, , b*57:03:02, , b*57:07, b*57:09, b*57:12, b*57:17, b*57:28n, b*57:39, b*57:42, b*57:46, b*57:57, b*57:63, b*57:66, b*57:70, b*57:80, b*57:82, b*58:08:01, b*58:08:02, b*58:20, b*58:27, b*58:28:01, b*58:28:02, b*58:65, and b*58:73 during analysis. the lot specific user documents and software uch files contain the incorrect allele specificity information for these two primer mixes.
  • Acción
    Manufacturer to issue advice regarding use

Device

AllSet = Gold SSP

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd