Ellume Faces Class-Action Suit After Class I Recall Of COVID-19 Tests
The lawsuit, filed in Maryland federal court, says Ellume should’ve offered refunds to people who bought later-recalled COVID-19 tests from the company.
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Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.