An Australia-based company is recalling thousands of coronavirus tests after discovering some Ellume COVID-19 home tests deliver higher-than-anticipated false positive results.
Ellume became the first company to gain Food and Drug Administration authorization to sell consumers kits at major retailers such as Walmart, CVS, Target and Amazon. The kits don’t require a prescription and deliver results in minutes.
But the company discovered false positive results at higher rates than the company’s original clinical studies showed and “isolated the cause and confirmed that this incidence of false positives is limited to specific lots.”
The company has recalled 43 lots shipped from April through August to retailers, distributors and the Department of Defense. Customers can check the lot number on the test’s carton and check whether it is among the recalled lots listed at www.ellumecovidtest.com/return. Or customers can call 1-888-807-1501 from 9 a.m. to 5 p.m. Eastern time, Monday through Friday.
Ellume said affected customers will be notified through the Ellume COVID-19 home test app. Within two weeks, the company will email consumers who tested positive with a recalled product, the company said.
Consumers who did not get a second, confirmatory test after testing positive with a recalled Ellume test should be aware their test result could have been wrong, the company said. Also, customers who tested positive using a recalled test kit should not assume they are immune to COVID, Ellume said.
In a statement, Ellume CEO Sean Parsons apologized to customers who experienced “stress or difficulties” from a false positive result.
“You have my personal commitment that we have learned from this experience, we have implemented additional controls, we are continuing to work on resolving the issue that led to this recall and we are going to do everything in our power to regain your trust,” Parsons said.
USA TODAY last month reported that several consumers who purchased Ellume tests complained about false positive results when compared with laboratory-based PCR tests. Several consumers have written complaints about false positive results on CVS and Amazon’s customer feedback portals.
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Last month, Parsons acknowledged some customers were getting false positive results and said the test is calibrated to detect more cases than other rapid antigen tests. At the time, Parsons said the company had discussed with federal regulators possible updates “to the decision-making process of the test” and “we hope that with their blessing, we’ll be able to roll that out in the future.”
Ellume said the recalled lots had false-positive test rates higher than the company’s clinical study data submitted to the FDA showed. The company did not say what percentage of recalled tests delivered false positives.
In clinical trials, when used on people with symptoms, Ellume correctly identified 96% of positive samples and 100% of samples without the virus compared with a lab-based PCR test. Ellume’s accuracy figures dropped when used by people without symptoms; 91% of positive samples and 96% of negative samples were correctly identified.
Ken Alltucker is on Twitter as @kalltucker or can be emailed at email@example.com.