Ellume recalls 2.2M home tests due to risk of false positives November 11, 2021 Auto Bot Covid-19 testing, Diagnostics, ellume, FDA, Policy 0 The company expanded a recall of its at-home Covid-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.