Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - POLYMYXIN B

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
    43605
  • Event Risk Class
    I
  • Event Initiated Date
    2017-01-23
  • 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 a study conducted on etest? polymyxin b with 180 clinical strains (pseudomonas aeruginosa acinetobacter and enterobacteriaceae) an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest? polymyxin b results are interpreted using clsi breakpoints.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - POLYMYXIN B
  • Model / Serial
    Model Catalog: 533408 (Lot serial: More than 10 lots contact mfr); Model Catalog: 533400 (Lot serial: More than 10 lots contact mfr)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - POLY
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.