Events

Retiro De Equipo (Recall) de Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885

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 Ortho-Clinical Diagnostics Inc.

¿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
    15699
  • Fecha de inicio del evento
    2013-11-22
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Causa
    Ortho clinical diagnostics (ocd) determined that vitros® chemistry products k+ slides, coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. ocd has conducted testing that indicates that vitros® k+ slides made from coatings 0884 and 0885 are currently meeting their intended use and performance specifications. however, at this time we are unable to determine the effect that the addition of the surfactant may have on long-term product performance.
  • Acción
    Product to be destroyed

Device

Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885

Manufacturer

Ortho-Clinical Diagnostics Inc