Events

Recall of OXOID LEGIONELLA PNEUMOPHILA 2-14 REAGENT

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
    46544
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-14
  • 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 technical investigation has confirmed that legionella pneumophila 2-14 reagent lot: 1265366 may return false negative results. this reagent is contained within the following products: oxoid legionella latex test (dr0800m) lots 1314413 and 1301907. continued use of these lots may result in a delay to the correct serogroup characterisation of legionella isolates.

Device

OXOID LEGIONELLA PNEUMOPHILA 2-14 REAGENT
  • Model / Serial
    Model Catalog: DR0802M (Lot serial: 1265366); Model Catalog: DR0802M (Lot serial: 1265362)
  • Product Description
    OXOID LEGIONELLA PNEUMOPHILA 2-14 REAGENT
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY