Events

Retiro De Equipo (Recall) de Sysmex

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 Roche Diagnostics GmbH.

¿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
    21687
  • Fecha de inicio del evento
    2017-07-14
  • 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
    It has been reported that a possible mix up of results could occur during 'user modification' of a barcode misread in the following circumstances:, 1. di-60 encountered a problem reading the barcode when processing a slide (slide 1) and a picture of the barcode for slide 1 is taken by the di-60., 2. when this occurs the di-60 provides slide 1 with a temporary order id based on the date and time (ie erryyyymmddhhmmss) and the image of the barcode picture (taken in step 1) is stored in the database and displayed in the order data dialogue against this err id., 3. following this, a slide (slide 2) from the slide maker/stainer (sp-10) which has had a barcode misread occurring on the sp-10 and has been.
  • Acción
    Manufacturer to issue advice regarding use

Device

Sysmex

Manufacturer

Roche Diagnostics GmbH