FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests

In recent months, the FDA has expended a lot of energy warning providers and patients to be on the lookout for and refrain from using at home, over-the-counter (OTC) COVID-19 tests that aren’t properly authorized. Now a new and potentially more concerning version of the problem has emerged: counterfeit tests. On April 29, the agency published a new communication warning that counterfeit tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.

The Counterfeit Danger

Although they look just like the real deal, the FDA stresses that the counterfeit tests have not been authorized, cleared, or approved by the agency for use or distribution in the US market. “The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests,” the agency said in its communication. The problem is that people who use and rely on the phony tests are putting themselves and others at risk. The danger is especially pronounced with a false negative result, which may cause those who actually have contracted the virus to not seek treatment that they really need, while believing that they can safely go out in public without endangering other people. False positive results can also cause problems to the extent they can cause people who are sick but don’t have COVID-19 to not get a proper diagnosis and receive the right treatment for whatever illness they do have. People who falsely test positive may also be housed with individuals who actually do have COVID-19, putting them at risk of infection, the FDA adds.

Red Flags of Counterfeit Tests

The first line of defense against counterfeit COVID-19 tests is recognizing that they’re out there. The FDA has also created and plans to update a special page on its website dedicated to counterfeit COVID-19 tests listing red flags that people can look out for to spot the counterfeits, including:

• Poor print quality of images or text on the product’s outside box label or the use instructions inside the box;
• Missing information on the outside box label, such as the lot number, expiration date or barcode or QR codes;
• Missing instructions;
• Grammatical or spelling errors in the product labeling;
• Kit components that don’t match the content description, such as missing components or more or less components than the box lists the kit is supposed to contain;
• The product trade name printed on the component or box labels differs from the authorized labeling found on the FDA website; and
• The box label or printed use instructions look different from the authorized labeling found on the FDA website.

The FDA webpage also lists the names of counterfeit kits to watch out for, which currently (as of May 11, 2022) includes:

• Counterfeit Flowflex COVID-19 Test Kits
• Counterfeit iHealth COVID-19 Antigen Rapid Test Kits

In addition, the FDA warns that if you have what you suspect to be a counterfeit test, you shouldn’t use it. Contact the distributor or store where you bought the test to tell them that you have a counterfeit test, and also inform the manufacturer of the authorized test. The manufacturer may ask for additional information such as photos of the packaging to further investigate the issue. After providing any requested information to the distributor and/or manufacturer, follow the manufacturer's instructions for returning or disposing of the test.