Events

Recall of NUCLISENS EASYMAG - MAGNETIC SILICA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33508
  • Event Risk Class
    I
  • Event Initiated Date
    2016-11-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    NUCLISENS EASYMAG - MAGNETIC SILICA;NUCLISENS MAGNETIC EXTRACTION REAGENTS
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.