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2 million COVID home tests recalled for false positives

The U.S. Food and Drug Administration says it’s a Class 1 recall, the most urgent type, for the...
The U.S. Food and Drug Administration says it’s a Class 1 recall, the most urgent type, for the Ellume COVID-19 home tests.(Ellume via CNN Newsource)
Published: Nov. 11, 2021 at 1:19 PM EST
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(CNN) - More than 2 million at-home COVID-19 tests are being recalled due to a high number of false positive results.

The U.S. Food and Drug Administration says it’s a Class 1 recall, the most urgent type, for the Ellume tests.

Regulators say false positives could lead to a delayed diagnosis or treatment of the actual cause of a person’s illness.

There have been 35 reports of false positives. No deaths have been reported.

The FDA says the reliability of negative test results is not affected.

The tests were manufactured between Feb. 24 and Aug. 11 and distributed from April 13 to Aug. 26.

Those who received a positive result with an Ellume test are advised to have a follow-up test.

The Biden administration in February awarded nearly $232 million to Ellume to produce its at-home tests.

This fall, the administration announced billions more dollars to help make more tests available.

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