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More Imports Of Counterfeit OTC COVID-19 Tests Reaching US

Executive Summary

Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported and sold in US. Alert also tells consumers how to spot counterfeit tests.

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Florida Dental Products Firm Fails Regulatory Checkup With COVID-19 Claims

Products Iotech International sells to health care providers and consumers are deemed unapproved new drugs and are misbranded due to claims to prevent and treat COVID-19. ACON Laboratories determined Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) is for sale in US without approval.

FDA Warns Against Use Of 3 Unapproved COVID-19 Tests

The agency says the diagnostics could produce inaccurate results, which may delay proper treatment and further the spread of COVID-19.

OTC COVID-19 Tests Without Clearance For Sales Smuggled Into US

Korean firm investigating how the test was imported and “strengthening contract terms and their enforcement” with distributors to curb “further attempts at illegal importation.” FDA granted an EUA in December for a different test made by firm.

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