Australian medical company recalls at-home COVID-19 tests in U.S. due to false positive results

In a statement the company said nearly 200,000 of the tests shipped to the U.S. were affected.

Published: October 7, 2021 4:36pm

Updated: October 7, 2021 5:03pm

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.