An Australian manufacturing company has recalled nearly 200,000 at-home COVID-19 tests in the U.S. due to the potential for false-positive test results.
According to NTD news, the Ellume manufacturing company received emergency authorization by the Food and Drug Administration in December for their nonprescription COVID test for people aged 2 and older.
The Biden administration inked a $231.8 million deal, initially approved by the Trump administration last year, to produce the test kits, and to reserve 8.5 million units for the U.S. market.
A manufacturing issue reportedly caused false-positive test results in some lots. The FDA said that it began alerting people earlier this week of the false test results, prompting the recall.
The Ellume company said in a statement that some 195,000 tests out of 3.5 million shipped to the U.S. were affected.