Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEICOPLANIN

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
    35426
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-14
  • 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 an assessment of etest teicoplanin with staphylococcus spp. it has been observed that even though the mic essential agreement at +/- 1 dilution is les than 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp. an underestimation of mic values by at least 1 dilution has been observed for coagulase negative staphylococci (cons). this underestimation leads to a risk of false susceptible results linked in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study the false susceptible rate observed was 37.5% for cons where strains with an mic at 8 mg/ml by the reference method (resistant) can be found susceptible by etest teicoplanin.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEICOPLANIN
  • Model / Serial
    Model Catalog: 522018 (Lot serial: More than 10 lots-contact man.); Model Catalog: 412461 (Lot serial: More than 10 lots-contact man.)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEIC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.