The U.S. Food and Drug Administration has recalled E25Bio rapid COVID-19 tests because the tests were not approved by the agency, may give false results, and may injure the user.
This is a “Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the FDA said in a news release Friday.
The tests are sold under the product name E25Bio COVID-19 Direct Antigen Rapid Test and the trade name E25Bio SARS-CoV-2 Antigen Test Kit. Consumers who purchased the tests should throw them in the trash and health care providers who used the tests should consider re-testing patients.
“E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA,” the FDA said.
“Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.”
The FDA said the kit may give users false-positive or false-negative results, which could result in the spread of the virus or a person delaying medical treatment.
The kits instruct users to obtain samples from deep inside the nose or throat, which could injure consumers, the FDA said.
“Only trained health care providers should collect these types of swab samples to prevent serious injury,” the FDA said, noting there have been no reports of such injuries.
Most at-home COVID tests require consumers to collect a sample with a nasal swab.
The FDA issued an alert on Feb. 4 warning consumers not to use the tests and posted the recall notice Friday. The company sent a letter to consumers in January telling them not to use the tests.