RecallGuardianCanada
Medical devices· Updated August 5, 2022

Counterfeit COVID-19 antigen rapid test kits found in Ontario

Standard priority
Recalled product: Counterfeit COVID-19 antigen rapid test kits found in Ontario
What you should do
  1. 1Canadians are advised not to use any of the components contained in these counterfeit kits regardless of how much they may resemble components found in other licensed COVID-19 test kits sold in Canada.
  2. 2Health Canada has no evidence to suggest that additional counterfeit kits have been distributed in Canada.
  3. 3If you suspect you have a counterfeit kit, do not use it and dispose of it in household garbage.
  4. 4Report suspected counterfeit medical devices to Health Canada.
  5. 5You can also report suspected counterfeit BTNX test kits to BTNX Inc. by calling toll-free at 1-888-339-9964, or by email at covid19@btnx.com with the subject line "Suspected Counterfeit BTNX Tests."What companies should knowIt is illegal to sell or advertise counterfeit health productsWhen non-compliance is confirmed by Health Canada, a number of compliance and enforcement options are available to correct non-compliance and mitigate the risk to Canadians including, for example, on-site visits, recalls, public communications, and product seizures.
The issue

Product safety

Affected product

Counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack)

Where it was sold

ONReported in the official notice — confirm there.

Issued by

Health Canada

Read the official Government of Canada notice

RecallGuardian ranks, illustrates and rewrites recalls in plain language. The official notice is authoritative — confirm model numbers, lot codes, dates and remedies there.

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