Events

Rappel de NUCLISENS EASYMAG - MAGNETIC SILICA

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOMERIEUX CANADA 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
    33508
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-11-23
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Following additional quality controls with a parameter (1 ml specimen/bk virus) which mimic the worst case condition a drift of the extraction performances was detected. this drift/decrease of performance after nuclisens easymag nuclisens minimag and emag extraction induced a difference superior to -05 log quantification on amplification assays on dna. this difference superior to -05 log is significant on results. as the downstream applications are qualitative and/or quantitative methods if the customer does not detect the issue the decrease of downstream application performance could lead to : 1. a risk of false negative for qualitative tests 2. invalid results when the internal amplification control is not on specifications. 3. under quantified results for quantitative tests.

Device

NUCLISENS EASYMAG - MAGNETIC SILICA
  • Modèle / numéro de série
    Model Catalog: 280133 (Lot serial: Z017NB1MS); Model Catalog: 280133 (Lot serial: Z017NA1MS); Model Catalog: 280133 (Lot serial: Z017MA1MS); Model Catalog: 280133 (Lot serial: Z017KB1MS); Model Catalog: 280133 (Lot serial: Z017KA1MS); Model Catalog: 280133 (Lot serial: Z017ND1MS); Model Catalog: 200293 (Lot serial: 16072701); Model Catalog: 280133 (Lot serial: Z017NC1MS); Model Catalog: 280133 (Lot serial: Z017LE1MS)
  • Classification du dispositif
    Hematology and Pathology Devices
  • Description du dispositif
    NUCLISENS EASYMAG - MAGNETIC SILICA;NUCLISENS MAGNETIC EXTRACTION REAGENTS
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.