Events

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

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
    17647
  • Fecha de inicio del evento
    2014-11-07
  • 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
    Bio-rad has confirmed that under specific conditions, the ih-1000 software may lose the link sample/"test in progress". this loss, might, in the worst case, lead to a mismatch between the test result and the sample., this issue is linked to the sample management when using the "emergency* button" and might occur only in the following conditions:, 1. a not urgent rack (green label) is inserted with more than one sample and ;, 2. all the samples on this rack are manually selected as "emergency" by clicking on the "emergency* button";, then once the first emergency sample is processed, the instrument ejects the rack before all processing is completed., 3. if a rack is then reloaded with new samples in the exact same positions and reinserted in the same slot, the link sample/"test in progress" is lost.
  • Acción
    Software to be upgraded

Device

Bio-Rad IH-1000 software
  • Modelo / Serial
    Model: Catalogue Number: 001000V, Affected: , Software version: All versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc