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Australian COVID-19 test maker Ellume says it will mount a vigorous defence in a lawsuit brought against it by consumers in the United States who claim the company failed to properly refund them after they purchased inaccurate tests.
The court action comes after Ellume, which inked a $300 million deal with the US government in 2021, was forced to recall 2.2 million test kits last year over concerns about higher than acceptable false positive rates.
Ellume resolved the manufacturing issue which led to the recall in 2021. Credit:AFR
The company has resolved the issue which led to the recall, but affected consumers have now launched proceedings in the United States District Court in the District of Maryland, arguing they have not received full refunds for tests which delivered false positives.
Indiana resident Karen Kerschen claims she spent $US65 ($87) on an Ellume test kit ahead of a trip to Ireland with her sister, so that she could show a negative result within 72 hours of returning back to the United States.
Court documents outline that she took an Ellume test in October 2021 in the days before her return to the US and returned a positive result. The operator of the tour she was taking advised that the whole tour group would have to isolate immediately, missing a day’s excursion and meal.
When she attempted to use her sister’s test kit to validate the result, she was advised via the app that the test had been recalled. Kerschen claims she eventually made contact with Ellume who advised her to “go out and buy another test kit”.
The tour company required that she receive a negative result, so she travelled to a testing site and paid for a different test, which showed her to be negative to the virus. It cost €40 ($58) to travel to the site and €99 ($143) for the test.
Kerschen alleges she contacted the company for a refund on return to the US but had not received one.
In a statement, an Ellume spokesman said the company was aware of the court action but it did not have merit. “Ellume also has provided refunds to most customers who used an affected test and received a positive result, even if the positive test result was accurate. The claims in this lawsuit are wholly without merit, and Ellume intends to mount a vigorous defence,” he said.