Posted August 13, 2020

FDA Warns Three More Companies Selling Unapproved COVID-19 Tests

Between July 23 and 24, the FDA issued warning letters to three companies for marketing unapproved, adulterated or misbranded antibody tests for coronavirus (COVID-19). The agency also emphasized to consumers that there are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home.

The companies that received a warning letter are as follows (use the links below to read the full warning letter):


These test kits were being sold in the US directly to consumers for at-home use without FDA authorization, and some falsely claimed that they had FDA approval.

The tests were promoted with statements such as "Now offering an AT HOME non-invasive stool test (PCR Technology Test) for individuals concerned about the current COVID-19 Virus" and "FDA Certified COVID-19 Rapid Test kit. This instant antibody test is simple to use. You do not need to see the doctor or even leave your house. Instructions are simple and on the package of each test'"

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?

See Related Warnings:

FDA Warns Companies Selling Unapproved COVID-19 Tests

KBMO Diagnostics Warned for Unapproved COVID-19 Test

Seller Indicted for Promoting Silver Product as Coronavirus Cure

FTC Sues Golden Sunrise for Marketing Deceptive $23,000 Coronavirus Cure

Sellers of Immune Boosters, Vitamin C Warned for Coronavirus Claims

Sellers of Miracle Mineral Solution Criminally Charged With Making Coronavirus Claims

Seller of Hand Sanitizer "Alternative" Warned for Coronavirus Claims