Recalls & Warnings
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Posted December 2, 2020
FDA Warns Sellers of Unapproved COVID-19 Tests, CBD Products
On November 23 and November 30, 2020, the FDA issued warning letters to Industry Lab Diagnostic Partners and Avazo-Healthcare, LLC, respectively, for selling unapproved, adulterated, and misbranded tests for coronavirus (COVID-19).
- COVID-19 Testing Kit (by Industry Lab Diagnostic Partners) was sold throughout the US, but it was not approved by the FDA, so it is adulterated and misbranded. The product instructed users to send a nasal swab sample for COVID-19 testing. However, the FDA warns that sample collection in the home with an unapproved test compared to a sample taken by a professional can have public health risks including if the user can safely and properly collect a sample and impacts on the specimen during shipping.
- COVID-19 Ag Rapid Test Cassette (Box of 25) for Qualitative Detection of SARS-CoV-2 Antigen in Swabs. CE. and COVID-19 Coronavirus Spike Glycoprotein Antigen Ag Rapid Test Kit by Sputum or Stool. CE. Box of 25. (by Avazo-Healthcare, LLC) are antigen tests that are unapproved, making them adulterated and misbranded. In addition, the company sells the serology test kit products COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). FDA EUA. Box of 25 and the FDA EUA CE Approved Coronavirus (COVID-19) IgM/IgG Rapid Test Kit by Assure Tech. Box of 20. While these products are FDA-approved, they are for limited-use only and not approved for resale by companies like Avazo-Healthcare.
An FDA director has previously spoken out against companies committing fraud to take advantage of the pandemic, stating, "When tests are marketed inappropriately, with inaccurate or misleading claims -- such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not -- they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted."
See ConsumerLab's answer to the question How can I get tested for the coronavirus? Can I get a home-test for COVID-19? Which are the best tests? Are any tests free?
The FDA also warned Avazo-Healthcare for selling CBD products with claims that they can treat or prevent COVID-19. Products were promoted with statements such as "COVID-19 AND CANNABIS?... Israeli researchers will utilize antiviral agents found in cannabis terpenes to slow the spread of the novel coronavirus... Other Israeli scientists have begun research into what role CBD could play in COVID-19 treatment."
See ConsumerLab's answer to the question: What are natural remedies for coronavirus (COVID-19)? Do supplements like zinc, vitamin C, or herbals work?
Also see ConsumerLab's CBD and Hemp Extract Supplements Review for tests of related products.
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