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
    14664
  • Fecha de inicio del evento
    2013-06-14
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Causa
    An error relative to the liquid reagents management (test cell or anti-serum vials) might occur if the following conditions are present:, 1. ih-1000 is in in status :ready to start"., 2. the user requests the unloading of a reagent rack while the system is creating the internal batch., 3. another is loaded immediateky afterwards in the same position., if all three conditions are present the ih-1000 may not use the full set of iquid reagents required to perform the tests of the ongoing batch., due to a software failure, the system mau only use the vial palced in the first position of the re-loaded rack for all the tests of the ongoing batch.
  • Acción
    Software to be upgraded

Device

Bio-Rad IH-1000 Analyser

Manufacturer

Bio-Rad Laboratories Inc