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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Recall Of Millions Of Ellume COVID-19 Tests High-Risk Class I, FDA Says
Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.
‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year
An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.