The Food and Drug Administration announced a Class 1 recall of the E25Bio COVID-19 Direct Antigen Response Test. 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. Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.
Due to the potential for false results, the FDA said health care providers who administered the test in the past two weeks and suspect an inaccurate result should consider retesting patients with an authorized test.
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