Recalls & Warnings
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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.
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