More than 200,000 COVID testing kits have been recalled after they gave false positive results due to an unknown manufacturing issue.
Ellume, an Australian company that supplied over 3.5 million FDA-approved Covid-19 testing kits to the US, has now recalled nearly 200,000 of them due to an unspecified manufacturing issue that resulted in false positives.
The Food and Drug Administration issued a notice on Tuesday alerting the public of “the potential for false positive results” with certain lots of Ellume’s Covid-19 Home Test, a rapid antigen kit used to detect the coronavirus using nasal swabs and a smartphone app.
Today, the @US_FDA issued a safety communication to alert test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume #COVID19 Home Test due to a recently identified manufacturing issue. pic.twitter.com/uYSJ9U4DBu
“Negative results do not appear to be affected by the manufacturing issue,” the FDA said, adding it is “working closely” with Ellume to assess “corrective steps” going forward.
People who used an Elume kit and received a positive r...