Prognosis
Home Covid Tests by Ellume Recalled Over False-Positive Reports
- Recall includes 195,000 test kits that had remained unused
- U.S. is investing in expanding the availability of rapid tests
Ellume home Covid-19 test units.
Photographer: PATRICK HAMILTON/AFP /AFP via Getty ImagesThis article is for subscribers only.
After complaints to U.S. regulators about false positives from a startup’s at-home Covid-19 test, the Australian company investigated and recalled hundreds of thousands of kits sold through stores and online, the U.S. Food and Drug Administration said.
Ellume Ltd. late last week announced a voluntary recall of about 195,000 tests that remained unused. Around 427,000 total tests were affected by a test component that left them more likely to return a false positive, a company spokeswoman said.