The U.S. Food and Drug Administration (FDA) has recalled hundreds of thousands of COVID-19 antibody and antigen tests following the discovery of fraudulent labeling practices. The recalled tests are not FDA-approved and may give inaccurate results.

On Jan. 28, 2022, the FDA issued an urgent safety communication regarding two COVID-19 tests distributed by Empowered Diagnostics: CovClear COVID-19 Rapid Antigen Test, a nasal swab test designed to detect antigen proteins, and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, a blood test that takes a fingerstick and analyzes the sample for antibodies. 

According to the FDA, these tests were marketed and labeled as being authorized by the FDA. However, according to the safety announcement, “Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.”

The FDA is now recommending that any healthcare provider who used the CovClear COVID-19 Rapid Antigen Test or the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test to test for Covid in the last two weeks retest with an authorized test and to report any false results. Following the safety announcement, the FDA also released a class I recall of the tests. 

The FDA has recalled all lots of CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test produced and distributed by Empowered Diagnostics LLC from Jan. 1, 2021 to Nov. 11, 2021. This encompasses over 286,000 tests nationwide. The recall also includes a section discussing Empowered Diagnostics’ response to the safety communication and recall notice.

As of the date of the recall, Empowered Diagnostics has sent all distributors and customers a voluntary recall email. While they have not provided the FDA with the specific instructions of that email, the company has told its customers to email the corporate sales representative for disposal and refund information.

The FDA has stated that although there have been no deaths or injuries, the dangers of false results can be harmful to individuals. A false-positive result can lead to loss of income and unnecessary isolation from loved ones and friends. A false-negative can lead to the user accidentally infecting others under the false presumption that they are in fact healthy. The FDA has emphasized that with the increase in cases spurred by the Omicron variant, accurate testing is more important now than ever.