FDA warns against use of certain unauthorized Covid antigen tests

The US Food and Drug Administration (FDA) has warned people against the use of unauthorised versions of certain Covid-19 rapid antigen tests currently being marketed in the United States. The warning was issued against unauthorised versions of Celltrion USA Inc’s DiaTrust Covid-19 Ag Rapid Tests.

The unauthorised Acon test comes in blue packaging, SD Biosensor in a white and magenta box and Celltrion’s in green and white packaging, according to the agency. It suggested consumers to compare the packaging to make sure they do not buy unauthorised tests.

It further said several fraudulent products are getting sold in the market that claims to cure, treat or prevent Covid-19 and added that such products, “haven’t been evaluated by the agency for safety and effectiveness and might be dangerous “. The US drug agency said that fraudulent Covid-19 products can come in many varieties, including dietary supplements and other foods, as well as products claiming to be tests, drugs, medical devices, or vaccines. The products cited include teas, essential oils, tinctures, and colloidal silver.

Showing concern over the use of unauthorised products, FDA said “these deceptive and misleading products might cause people to delay or stop appropriate medical treatment for Covid-19, leading to serious and life-threatening harm. It’s likely that the products do not do what they claim, and the ingredients in them could cause adverse effects and could interact and potentially interfere with medications to treat many underlying medical conditions”.

The FDA has also seen unauthorised fraudulent test kits for Covid-19 being sold online. “Working with retailers to remove dozens of misleading products from store shelves and online. The agency will continue to monitor social media and online marketplaces promoting and selling fraudulent Covid-19 products,” it added.

The FDA may send warning letters or pursue seizures or injunctions against people, products, or companies that violate the law. It said it is increasing the enforcement at ports of entry to ensure that fraudulent products do not enter the country through our borders.

In addition, the FDA is monitoring complaints of fake coronavirus treatments, vaccines, and tests. LiveMint