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FDA recalls 2.2 million at-home coronavirus tests due to false positives

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WASHINGTON - The FDA announced this week that the recall of more than 2.2 million at-home COVID-19 tests by digital diagnostics firm Ellume is being classified as a class 1 recall, which is the most serious type due to the potential for "serious adverse health consequences or death."Ellume's at-home test detects proteins from the SARS-CoV-2 virus through a less invasive nasal swab than the one that health providers normally use.

The recall is due to a "manufacturing issue" that was first identified by the company last month and could lead to a false-positive result.

The FDA said Wednesday that it has received 35 reports of false-positive test results, but noted that negative test results are still reliable and not affected by the.

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United States
United States
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Deaths: 750 423
Recovered: 0
India
India
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Recovered: 0
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Brazil
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Deaths: 608 235
Recovered: 0
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United Kingdom
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Deaths: 141 607
Recovered: 0
Russia
Russia
Cases: 8 494 589
Deaths: 237 619
Recovered: 0
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