Events

Rappel de Bio-Rad IH-1000 Analyser

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
    14664
  • Date de mise en oeuvre de l'événement
    2013-06-14
  • 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
    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.
  • Action
    Software to be upgraded

Device

Bio-Rad IH-1000 Analyser
  • Modèle / numéro de série
    Model: Product Ref: 001000, Affected: All software versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc