Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFOTAXIME

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX SA.

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
    132729
  • Event Risk Class
    I
  • Event Initiated Date
    2015-06-11
  • 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 internal investigation identified a performance deviation associated with quality control testing of retained product samples indeed the qc results were out of range resulting in false resistant strains.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFOTAXIME
  • Model / Serial
    Model Catalog: 505518 (Lot serial: 1002590470); Model Catalog: 505518 (Lot serial: 1002774320); Model Catalog: 505518 (Lot serial: 1002377890)
  • Product Classification
    Immunology and Microbiology Devices
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFO
  • Manufacturer
    BIOMERIEUX SA

Manufacturer

BIOMERIEUX SA