POMPANO BEACH, Fla. — Empowered Diagnostics LLC is recalling nearly 300,000 rapid COVID-19 tests that have not been cleared for use in the United States amid concerns that they could potentially provide false results.
The U.S. Food and Drug Administration characterized the recall as a Class 1, the most serious type issued, according to a news release issued jointly on Friday by the Pompano Beach, Florida-based company and the regulatory agency.
The recall affects at least 284,575 CovClear COVID-19 rapid antigen tests and at least 2,100 ImmunoPass COVID-19 neutralizing antibody rapid tests.
The tests have been distributed nationwide with labeling that incorrectly indicates that they are authorized by the FDA. According to the company’s website, the CovClear test is currently authorized in Canada and the European Union, Reuters reported.
The affected products were distributed between Jan. 1 and Nov. 11, 2021.
According to the recall, there have been no reports to date of adverse health consequences or deaths linked to use of the affected tests, but the FDA is “concerned about the potential high risk of false results when using unauthorized tests.”
Per the recall, the following people may be affected:
- People who were tested using these medical devices
- Health care providers who may have access to and use these tests or whose patients have used these tests
- Organizers of large testing programs, such as in the workplace or schools, who may be using and distributing these tests for diagnostic use
To learn more, read the complete recall here.
More coronavirus pandemic coverage:
>> Coronavirus: How long between exposure to the virus and the start of symptoms?
>> How to not let coronavirus pandemic fatigue set in, battle back if it does
©2022 Cox Media Group
/cloudfront-us-east-1.images.arcpublishing.com/cmg/XCUXZC2XYZHCRGNNGKFEX6U3LQ.png)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/WVVB4CJSSFHTHC275F4OJHSIGI.jpg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/IXYAXKZLYNE3DB5WTRMQZ6GX2I.jpg)
:quality(70)/d1hfln2sfez66z.cloudfront.net/04-24-2024/t_86f539c1ea764201a4839c265bde5024_name_turkscaicosdetain042424_frame_989.jpeg)
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/cmg/WBHBUR3P4JFHRCOLGEIYYXZL7U.png)
:quality(70)/d1hfln2sfez66z.cloudfront.net/04-25-2024/t_3cc0b1cdc436410b8d1b8d9a559e36d0_name_nviewheightsincident6pp042524_transfer_Consolidated_01.jpg)