Events

Retiro De Equipo (Recall) de BD CD8 Phycoerythrin (PE)

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
    17921
  • Fecha de inicio del evento
    2014-12-24
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    It has been identified that the cd8 pe reagent has been contaminated with a low amount of cd4 fitc. it has been confirmed that the concentration of the cd8 antibody in the oe conjugate is sufficient to detect cd8 antigen on the targeted cells however the presence of cd4 could result in the possibility of an unexpected staining pattern., the concern with the above issue is that the cd4 cells will be expressed along the fitc axis. any marker that is stained on the fitc axis will contain this incorrectly stained cd4 population. subsequent downgating will make the data appear as if the cd4 population is not present.
  • Acción
    Product to be exchanged

Device

BD CD8 Phycoerythrin (PE)

Manufacturer

manufacturer #1479