Events

Retiro De Equipo (Recall) de Bio-Rad- IH-1000 Analyser

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 Bio-Rad Laboratories 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
    14800
  • Fecha de inicio del evento
    2013-06-13
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Causa
    Under specific conditions inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed., this issue might lead to a wrong result released to the host if all the 3, following conditions are met:, 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation and,, 2. this negative result is consistent with the global interpretation of the test and,, 3. the system is configured without the second reading function activated for all tests results.
  • Acción
    Software to be upgraded

Device

Bio-Rad- IH-1000 Analyser

Manufacturer

Bio-Rad Laboratories Inc