Events

Rappel de Bio-Rad IH-1000 software

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Bio-Rad Laboratories Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    17647
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Bio-Rad IH-1000 software
  • Modèle / numéro de série
    Model: Catalogue Number: 001000V, Affected: , Software version: All versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc