Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLISTIN

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
    23702
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-26
  • 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
    Based on scientific publications (including eucast warning letter on their website) on colistin gradient and disk diffusion tests including etest colistin biomerieux was alerted about a potential underestimation of the mic values for entero bacteriaceae and acinetobacter biomerieux initiated a complaint investigation to confirm product performance and determine root cause. while the internal and external investigations are still ongoing.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLISTIN
  • Model / Serial
    Model Catalog: 537308 (Lot serial: More than 10 contact mfg); Model Catalog: 537300 (Lot serial: More than 10 contact mfg)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLI
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.