Events

Recall of THERMOSCIENTIFIC OXOID COLUMBIA BLOOD AGAR BASE

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
    138837
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-09
  • 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 identified that certain lots of oxoid columbia blood agar base cm0331 may not provide acceptable microbiological performance when used in selective formulations targeting staphylococcus and streptococcus spp. however these formulations continue to perform correctly with the qc strains detailed in the qc specs. performance with some clinical strains may be atypical.

Device

THERMOSCIENTIFIC OXOID COLUMBIA BLOOD AGAR BASE
  • Model / Serial
    Model Catalog: CM0331 (Lot serial: 1841146); Model Catalog: CM0331 (Lot serial: 1857212)
  • Product Description
    ThermoScientific Oxoid Columbia Blood Agar Base
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY