Ellume Recalls COVID-19 Home Tests for False Positives

October 11, 2021

Australia-based digital diagnostics company Ellume recalled specific lots of its COVID-19 Home Test, reportedly numbering in the hundreds of thousands, due to a risk of false-positive results.

The rapid, at-home antigen test, which is available without a prescription from major retailers, was granted Emergency Use Authorization by the FDA.

Ellume said specific product lots reported false-positive test result rates higher than was observed in clinical testing. The company said it has identified the root cause, implemented additional controls and is working on resolving the problem.  Distribution of tests to retail and distribution partners has begun.

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