Nearly 200,000 Home COVID-19 Tests Were Recalled Due to False-Positive Results

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Nearly 200,000 Home COVID-19 Tests Were Recalled Due to False-Positive Results
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You may need to call your doctor.

In the past few weeks, the company noticed that some of its tests were returning a higher amount of false-positive results than usual, Sean Parsons, Ellume CEO and founder, explained in a. That means the test gave someone a positive result for COVID-19 when they actually did not have the virus. “Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots,” Parsons continued.

identifies it as a manufacturing issue—and notes that negative results do not seem to be affected in the same way. The 195,000 recalled Ellume tests, which amount for about 5.6% of the total number of Ellume home COVID-19 tests in the country,says, were available through retailers and distributors. Some were also sent to the U.S. Department of Defense.

“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 continued in the statement. “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.

No matter how accurate a test is, there is always a potential for false-positive and false-negative results. Rapid tests like these haveof false-positive results depending on the specific brand and whether or not the person taking the test has noticeable COVID-19 symptoms.

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