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.
“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 result were instructed to contact their healthcare provider for a follow-up. Everyone who owns a kit is urged to check the Ellume-provided list of problematic lots, sent out between April and August this year, and request a replacement after submitting receipts.
Ellume CEO Dr. Sean Parsons said the company noticed the false positive result from specific product lots “in recent weeks” and isolated the cause. However, the company declined to elaborate what was causing the problem, citing trade secrets.
“The increase in false positives was the result of a supply chain issue with one of the test components. Because of the proprietary information involved in the manufacturing process, we cannot offer more specifics,” an Ellume spokesperson said in a statement.