Counterfeit COVID-19 antigen rapid test kits found in Ontario
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
| Field | Value |
|---|---|
| N I D | 78092 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/counterfeit-covid-19-antigen-rapid-test-kits-found-ontario |
| Issue | Product safety |
| Title | Counterfeit COVID-19 antigen rapid test kits found in Ontario |
| Product | Counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack) |
| Archived | 0 |
| Category | Medical devices |
| Last updated | 2022-08-05 |
| Organization | Communications and Public Affairs Branch |
| What you should do | 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. |