Recall Of Millions Of Ellume COVID-19 Tests High-Risk Class I, FDA Says
It’s the second coronavirus diagnostic to be slapped with a class I recall label
Ellume recalled 2,212,335 of the home tests because there’s a chance they can give false-positive results.
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Complaint filed in Maryland federal court says Australian firm, which received more than $230 from US government to boost production of its OTC COVID-19 diagnostic tests available to US consumers, should’ve offered refunds to consumers who bought tests the company has recalled due to false positive 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.
A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.