The American Food and Drug Administration (FDA), the government body that deals with the regulation of pharmaceutical products has announced the withdrawal from the market of more than 2.2 million DIY tests for the Ellume company due to potential “Serious adverse health or death consequences”.
It was the same company last month that disclosed a problem in the production of the nasal swab that could lead to false positives. 427,000 tests were initially recalled, up from well over 2 million this week. Of these, 660,000 have already been used giving 118,000 positive results. The FDA said it had received 35 reports of false positives but also stressed that the negative results are still reliable.
Ellume has already taken steps to resolve the problem: “We have investigated the matter, identified the causes, implemented additional checks, and we are already producing and shipping new products to the US,” he assured.