Events

Recall of NUCLISENS EASYMAG LYSIS BUFFER

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
    72657
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-06
  • 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
    The risk to use the product beyond the expiration date due to the incorrect label is to have false results. the severity level of the risk to obtain false results (due to the insufficient extraction) has been assessed as critical considering that the product is used in the extraction phase of the nuclisens and r-gene tests and it is also used always in the extraction phase in association with other kits not manufactured by biomerieux. medical affairs confirmed the severity of the issue as critical for adverse health consequences and mitigated the occurrence as remote (unlikely to occur but is possible).

Device

NUCLISENS EASYMAG LYSIS BUFFER
  • Model / Serial
    Model Catalog: 280134 (Lot serial: Z014GA1LB)
  • Product Description
    NUCLISENS EASYMAG LYSIS BUFFER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.