Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME

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
    23127
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-25
  • 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
    An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for a significant strains kit including enterobacteriaceae haemophilus and s. pneumoniae. species. then an additional analysis was done on the clinical categorization of the strains based on clsi guidance. the following have been identified: the investigation confirmed a potential performance issue on strains categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only. for streptococcus pneumoniae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains :false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method. false intermediate result instead of resistant results with bmd reference method _ for enterobacteriaceae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains: false susceptible result instead of intermediate results with ad (agar dilution) reference method. false intermediate result instead of resistant results with ad reference method products perform within the specification when using the 2016 eucast guidelines.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME
  • Model / Serial
    Model Catalog: 412305 (Lot serial: More than 10 contact manuf.); Model Catalog: 506918 (Lot serial: More than 10 contact manuf.)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFU
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.