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Health CanadaGeneral Alert

Counterfeit COVID-19 antigen rapid test kits found in Ontario

Published: August 5, 2022Recall ID: 78092Category: Consumer ProductsCountry: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Counterfeit COVID-19 antigen rapid test kits found in Ontario

Recalling Firm: Communications and Public Affairs Branch

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Reason for Recall / Hazard

Product safety

Product Description & Identification

Canadians 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.Health Canada has no evidence to suggest that additional counterfeit kits have been distributed in Canada.If you suspect you have a counterfeit kit, do not use it and dispose of it in household garbage. Report suspected counterfeit medical devices to Health Canada. You 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 primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Affected Products

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

Additional Source Details

FieldValue
N I D78092
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/counterfeit-covid-19-antigen-rapid-test-kits-found-ontario
IssueProduct safety
TitleCounterfeit COVID-19 antigen rapid test kits found in Ontario
ProductCounterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack)
Archived0
CategoryMedical devices
Last updated2022-08-05
OrganizationCommunications and Public Affairs Branch
What you should doCanadians 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.Health Canada has no evidence to suggest that additional counterfeit kits have been distributed in Canada.If you suspect you have a counterfeit kit, do not use it and dispose of it in household garbage. Report suspected counterfeit medical devices to Health Canada. You 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 primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Counterfeit COVID-19 antigen rapid test kits found in Ontario?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmCommunications and Public Affairs Branch
Recall Hazard Severity
Caution (Class III)
Official Agency Alert

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