Events

Rappel de Bio-Rad D-10 Hemoglobin Testing System

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 manufacturer #1479.

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
    16350
  • Date de mise en oeuvre de l'événement
    2014-03-05
  • 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
    On a rare occasion the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample., the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. we recommend carefully reviewing the daily summary and/or the printed chromatograms for duplicate injection numbers or sample ids. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Action
    Manufacturer to issue advice regarding use

Device

Bio-Rad D-10 Hemoglobin Testing System
  • Modèle / numéro de série
    Model: Catalogue Number: 220-0220, Affected:
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479