Save to favorites
This feature is restricted to active members.
Join now to save favorites and get all member benefits, including over 1,300 reviews.
Join NowAlready a member? Sign in here.
Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted June 20, 2020
FDA Warns Companies Selling Unapproved COVID-19 Tests
The companies that received a warning letter are as follows (use the links below to read the full warning letter):
- Medakit Ltd (COVID-19 Rapid Test Kit)
- antibodiescheck.com (Antibodies Test Kit for Covid19)
- Sonrisa Family Dental dba www.mycovidtest19.com (Cellex Test Kit, Leccurate Test Kit)
Some of the test kits were being sold in the US directly to consumers for at-home use without FDA authorization and/or included labels that falsely claim FDA approval or bear the FDA logo, which is for the official use by the FDA only, and not for use on private sector materials.
The tests were promoted with statements such as "Our diagnostic tests can be used anywhere, anytime, making it possible to provide simple, quick, accurate, and affordable results" and "MyCOVID19 Testing Club includes 15 minute Covid tests for the whole family!"
An FDA director spoke 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?
See Related Warnings:
Seller of Silver and Vitamin C Lozenges & More Warned for Coronavirus Claims
FTC Warns 35 More Companies for Coronavirus Claims
FDA Warns Sellers of CBD, Colloidal Silver, Essential Oils, and More Promoted to Treat Coronavirus
Seller of Vitamin and CBD "NoronaPak" Warned for Coronavirus Claims
FTC Warns 50 More Companies for Coronavirus Claims
FDA Warns Sellers of CBD, Kratom, Vitamin C, and More for Coronavirus Claims
Plum Dragon Herbs Warned for Coronavirus Claims
For more information, use the link below.
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
