Covid RAT test supplier hit with class action

An Australian manufacturer of coronavirus rapid antigen tests in the US is facing a class action.

An Australian manufacturer of coronavirus rapid antigen tests is facing legal action in the United States after millions of kits were withdrawn over false positive results.

It is alleged that Ellume failed to provide its customers with refunds after they falsely tested on the kits.

Brisbane-based biotech Ellume – which produced the first, over-the-counter, rapid coronavirus antigen test kit to be approved by the US Food and Drug Administration (FDA) – was forced to recall around 2 million kits in the US in October and November 2021 over the issue.

The FDA said that the recall of the Ellume Covid-19 Home Test kit constituted the most serious kind of recall (Class I).

It said false positives could result; in delayed diagnosis or treatment, a person receiving treatment they did not require, or isolation from work, school, family or friends.

At the time the FDA produced its notice in November 2021, it said 35 people had received false positives from the kits.

The biotech was forced to recall approximately 2 million of its Ellume COVID-19 Home Test kits in the US in October and November 2021. Picture: Getty Images

Ellume have since addressed the issue associated with the recall, but now customers have now initiated legal action in the United States District Court in the District Court of Maryland alleging that they have not received full refunds for the faulty kits that they purchased.

The first plaintiff, Karen Kerschen, alleges that she purchased an Ellume Covid-19 Home Test Kit for USD $65 (AUD $113.93) prior to travelling to Ireland which showed a positive result.

Ms Kerschen’s positive result led her and her entire tour group to have to isolate immediately and miss activities that they had previously paid for. Ms Kerschen then paid for a different test which rendered a negative result. She alleges that she contacted Ellume to be reimbursed but had not received any compensation since.

The second plaintiff, Wallace Lovejoy, claims that he and his spouse missed their trip to the United Kingdom due to his wife testing positive for coronavirus via an Ellume Covid-19 Home Test kit.

Consequently, Mr Lovejoy’s wife undertook a PCR test which gave a negative result. In Mr Lovejoy’s case, he said that he received a cheque by post from Ellume for US$215 (AUD $288.17) but said that this did not meet the full cost of the eight test kits that he had purchased which were USD$538 (AUD $721.10)

The Plaintiffs, together with the class, are alleging that they did not receive full refunds for the faulty Ellume COVID-19 Home Test kits. Picture: Getty Images

The complainants allege that the biotech organisation had “unjustly retained” the monies that customers had spent on the faulty DIY testing kits and had “unjustly enriched itself at the expense of Plaintiffs and Class members”.

The legal proceedings seek to include all those who have purchased DIY COVID-19 Home Test kits and received a false positive result.

Ellume’s COVID-19 Home Test kits are not available in Australia for use as yet.

News.com.au has contacted Ellume for comment.