Events

Recall of ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN

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
    33638
  • Event Risk Class
    III
  • 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
    As a part of an ongoing project regarding the analysis of stability data on etest range we have observed a decrease in the shelf life of the following etest products that requires your immediate attention to ensure improved use of the product within its revised shelf life of (24) months.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN
  • Model / Serial
    Model Catalog: 529108 (Lot serial: More than 10 contact manuf.); Model Catalog: 513610 (Lot serial: More than 10 contact manuf.); Model Catalog: 512518 (Lot serial: More than 10 contact manuf.); Model Catalog: 512510 (Lot serial: More than 10 contact manuf.); Model Catalog: 506718 (Lot serial: More than 10 contact manuf.); Model Catalog: 535918 (Lot serial: More than 10 contact manuf.); Model Catalog: 529100 (Lot serial: More than 10 contact manuf.); Model Catalog: 513618 (Lot serial: More than 10 contact manuf.); Model Catalog: 525518 (Lot serial: More than 10 contact manuf.); Model Catalog: 525510 (Lot serial: More than 10 contact manuf.); Model Catalog: 522718 (Lot serial: More than 10 contact manuf.); Model Catalog: 502518 (Lot serial: More than 10 contact manuf.); Model Catalog: 508618 (Lot serial: More than 10 contact manuf.); Model Catalog: 508610 (Lot serial: More than 10 contact manuf.)
  • Product Description
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN FM 1024 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - IMIPENEM IP 32 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - GENTAMICIN GM 256 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTAZIDIME TZ
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.