Events

Recall of TB POTASSIUM PERMANGANATE

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

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
    67213
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-06
  • 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
    A technical investigation has confirmed that the referenced product remel tb potassium permanganate may appear cloudy or discolored and may not perform correctly. continued use of this lot could cause false negative detection of tubercle bacilli in patient specimens.

Device

TB POTASSIUM PERMANGANATE
  • Model / Serial
    Model Catalog: R40192 (Lot serial: 293086)
  • Product Description
    TB POTASSIUM PERMANGANATE
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY