Events

Retiro De Equipo (Recall) de Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

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
    15144
  • Fecha de inicio del evento
    2013-08-15
  • 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
    The vitros microslide cartridge is made up of the cartridge body and an anti-backup platen(abp). the purpose of the abp is to keep the stacks of slides in the correct position for dispensing. ortho clinical diagnostics have received reports associated with abp failing to advance, jamming or failing to stay locked in place within the cartridge. when this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly.
  • Acción
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

Manufacturer

Ortho-Clinical Diagnostics Inc