FDA recalls 2 million at-home COVID tests because of high false positives

The FDA and manufacturer Ellume have recalled more than 2 million at-home COVID-19 test kits because of a higher-than-expected false positive rate, the Hill reported Thursday.

The recall for a few thousand test kits was first issued in October but has now expanded after more reports of false positive tests.

The recall was identified as a Class 1 recall, which is the most serious type. Class 1 recalls “may cause serious adverse health consequences or death,” the FDA said.

It was not clear how a false positive COVID-19 test could cause serious health consequences or death, but those who received a positive result from an Ellume at-home test are being advised to confirm the results with a second molecular test.

False positives reported

So far, 35 false positive test results have been identified and reported to the FDA, and no deaths have been reported.

Negative test results are still valid, the FDA and Ellume said.

Unused test kits, which work with an analyzer through a mobile app, are being disabled through a software update.

The Biden administration has a $232 million deal with Ellume to produce and provide the test kits.

CEO apologizes

Ellume CEO Sean Parsons apologized in a statement on the company’s website for the problems with the kits.

“We understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,” Parsons said. “To those individuals, I offer my sincere apologies — and the apologies of our entire company — for any stress or difficulties they may have experienced because of a false positive result.”

The at-home tests are used by those who want a rapid result before going to work or sending a child to school. Results are typically available in 15 minutes.

Demand for the tests has been high, and supplies have been limited until recently. The Biden administration just spent another $1 billion to purchase millions more rapid tests to meet the high demand for them.

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