Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM

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
    87481
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-06
  • 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 the strain epidemiology evolution with the detection of some streptococcus resistant strains from clinical specimens (around 1 and 5% according to clsi breakpoints) that did not exist at the moment of the product registration and as a part of the etest etp32 change impact study biomerieux initiated an internal study. the investigation results confirmed a potential performance issue on strain categorization for s. viridans group and s. pneumoniae based on 2017 clsi and eucast breakpoints that could lead to false susceptible result instead of resistant results on etest? etp32 (ertapenem) blister packaging when comparing to the broth-micro dilution (bmd) reference method. this performance issue was not evaluated at the time of product registration because rare or no resistant strains were reported at this time.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM
  • Model / Serial
    Model Catalog: 531600 (Lot serial: More than 10 contact manuf.)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTA
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.