Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTRIAXONE

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
    16882
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-28
  • 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
    412303: etest ceftriaxone - spb packaging as a part of our ongoing thorough analysis of the etest product range we have observed internally two issues with etest ceftriaxone txl32 (ref. 412303) spb packaging that may affect the test performance. 507018 : etest ceftriaxone txl32 - foam packaging: as a part of our ongoing thorough analysis of the etest product range we have observed internally two issues with etest ceftriaxone txl32 (ref. 507018) foam that may affect the test performance.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTRIAXONE
  • Model / Serial
    Model Catalog: 507018 (Lot serial: More than 10 contact manuf.); Model Catalog: 412303 (Lot serial: More than 10 contact manuf.)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTRIAXONE TXL32
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.