Events

Recall of THERMOSCIENTIFIC OXOID REMEL NITRATE REAGENT B FOR AFB BTL/25ML

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
    17832
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-09
  • 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 confirmed customer reports that qc positive controls failed the nitrate reduction test with this lot of remel nitrate reagent b for afb.

Device

THERMOSCIENTIFIC OXOID REMEL NITRATE REAGENT B FOR AFB BTL/25ML
  • Model / Serial
    Model Catalog: R21244 (Lot serial: 787147)
  • Product Description
    THERMOSCIENTIFIC OXOID REMEL NITRATE REAGENT B
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY