FDA Recalls E25Bio Rapid COVID-19 Antigen Tests

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FDA Recalls E25Bio Rapid COVID-19 Antigen Tests
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🚨RECALL ALERT: The FDA 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 aThe 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.

“Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized.”

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