Australian medical tech manufacturer Ellume said it has recalled almost 200,000 at-home Covid-19 tests in the United States over an increased chance of false positives.
The US Food and Drug Administration issued an alert on Tuesday over the “potential for false positive results with certain lots of the Ellume Covid-19 Home Test, due to a recently identified manufacturing issue”.
“Negative results do not appear to be affected by the manufacturing issue,” the statement said.
A spokesman for Ellume told AFP that 195,000 of the 3.5 million tests shipped to the United States had been affected.
