FDA Issues Safety Alert For Ellume COVID-19 Tests; Warns Of False Positives
Users of some Ellume at-home nasal swab tests might have received inaccurate results, FDA says.
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Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.
The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.
Ellume Health’s COVID-19 Home Test isn’t just a relatively fast, accurate and easy-to-administer antigen diagnostic, but it’s also available over-the-counter, which greatly expands public access to such tests.