Events

Retiro De Equipo (Recall) de Roche ProCell/CleanCell Aspiration Tube Filters

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
    16654
  • Fecha de inicio del evento
    2014-05-08
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    The manufacturer has identified that under certain conditions the white aspiration tube/filters on the end of the procell and cleancell aspiration tubes may become loose or fall off the aspiration tube completely. this in turn may allow air to enter the aspiration tube, creating foam. the liquid short sensors (lss) are unable to detect these very small bubbles. foam may be visible in the procell and cleancell reservoirs. if foam reaches the measuring cells, this may cause discrepant results. the magnitude of the discrepancy will vary with the amount of air being aspirated, particularly for procell.
  • Acción
    Instructions for use to be updated

Device

Roche ProCell/CleanCell Aspiration Tube Filters
  • Modelo / Serial
    Model: Part number: 03149773001, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479