A australian company withdrew more than two million home tests to diagnose Covid-19 sended to USA after discovering a higher than expected number of false positives, indicated the US drug agency FDA.
This regulator reported on Wednesday that the company Ellume had withdrawn 2.2 million since the detection of this problem last month and that, to date, they have registered 35 cases of false positives.
In early October, Ellume announced the voluntary recall of 195,000 tests after false positive results were detected at a higher than expected rate in some batches.
The Australian firm, which had exported 3.5 million tests to the United States, said Thursday that the recall was extended to other batches also affected.
“Ellume has investigated the issue, identified its origin, implemented additional controls and we are already producing and shipping a new product to the United States,” he said.
This company’s domestic tests were the first to receive authorization for use in the United States the previous year.