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 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
    135129
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-17
  • 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
    The manufacturer identified a performance issue on the etest foam ertapenem (ref # 531610 and 531618) and etest single pack ertapenem (ref #412332). these strips didn't give the correct mic (minimum inhibitory concentration) for some of quality control strains.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM
  • Model / Serial
    Model Catalog: 531618 (Lot serial: >10. Contact manufacturer); Model Catalog: 412332 (Lot serial: >10. Contact manufacturer); Model Catalog: 531610 (Lot serial: >10. Contact manufacturer)
  • Product Description
    Etest Ertapenem Foam ETp 32
  • Manufacturer
    BIOMERIEUX SA

Manufacturer

BIOMERIEUX SA