Events

Recall of NUCLISENS 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
    65303
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-10
  • 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 a customer complaint related to coloured eluates for whole blood extractions when using nuclisens lysis buffer ref 200292 - lot 17022802 an r&d investigation showed that the eluate becomes coloured because of the presence of the group heme.

Device

NUCLISENS LYSIS BUFFER
  • Model / Serial
    Model Catalog: 200292 (Lot serial: 17022802)
  • Product Description
    NUCLISENS LYSIS BUFFER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.