Save to favorites
This feature is restricted to active members.
Join now to save favorites and get all member benefits, including over 1,400 reviews.
Join NowAlready a member? Sign in here.
Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted December 22, 2021
Unauthorized Rapid Antigen Test Gets FDA Warning
On December 1, 2021, the FDA issued a warning letter for DermaCare Biosciences, LTD. following a review of the company's websites and social media, which found the company promoted the sale of the Easy Rapid Now COVID-19 Nasal Swab Antigen Test without marketing approval, clearance, or authorization from the FDA, making the product adulterated and misbranded.
The COVID-19 test was promoted with statements such as, "Mass Surveillance. Protect Classrooms, Workplaces, and Other Populations," and "Rapid detection of SARS-CoV-2 nucleocapsid antigen in less than 15 minute[sic]," confirming the company's COVID-19 Test is intended for screening and diagnosis.
Because this product was sold without approval, clearance, or authorization from the FDA while claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 in people, the FDA has instructed immediate action to cease the sale of unapproved, uncleared, and unauthorized products. The company was also advised to send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps it has taken to correct these violations.
See ConsumerLab's reviews of rapid antigen tests, including its Top Pick among these tests.
For more information, use the link below.
Warning Letter: DermaCare Biosciences, LTD.
See Related Warnings:
FDA Warns Seller of "CoronaBox" Containing Vitamin D, Probiotics & More for Unsupported Claims
Colloidal Silver Seller Warned for COVID-19 Claims
Seller of Vitamin C, Elderberry, Silver, and More Warned for COVID-19 Claims
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.
