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Health Canada issued a warning related to counterfeit COVID-19 immediate verification kits discovered in Ontario.
The kits, which were sold online through an unlicensed distributor, are counterfeit BTNX Rapid Response COVID-19 antigen verification kits (boxes of 25), and distributor Healthful Plus did not have the license to import, distribute or sell medical devices in Canada.
“The packaging of the counterfeit kits resembles the authentic (licensed) BTNX Inc. in color and font and uses the BTNX Inc. device identifier. “COV-19C25,” the Health Canada statement reads.
But unlike authentic BTNX kits, counterfeit kits are classified as manufactured through “Health Advance Inc. “instead of BTNX Inc. , while identifying Health Advance as the “Official Canadian Distributor”. They also come with the text “Approved by Health Canada”, No claims of approval through the government are allowed.
Other tips for spotting counterfeit kits are the fact that authentic boxes are sealed with a clear label with blue letters saying “QC APPROVED” and that counterfeit boxes have varying contents. The lot number (beginning with the letter “I”) and the expiry date of the green cassette envelope must also match the batch number and the expiry date of the carton.
“The protection and effectiveness of those counterfeit kits have been evaluated through Health Canada,” fitness canada said.
The entire shipment containing 435 boxes of potentially counterfeit kits was sent to Health Canada for compliance tracking.
Health Canada said there was no evidence to recommend that more counterfeit kits be distributed in Canada; however, those who suspect that they possibly have a counterfeit kit do not use it and throw it away.
Medical devices suspected of being counterfeit can be reported through Health Canada’s online forms. Counterfeit BTNX verification kits can also be reported to BTNX Inc. by calling toll-free at 1-888-339-9964 or by emailing covid19@btnx. com with the topic “BTNX Evidence Suspected of Counterfeiting. “
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