Manufacturer recalls thousands of COVID-19 test kits over ‘false positives’

*An internal investigation isolated the cause of the defect, and confirmed that this incidence of false positives is limited to specific lots of the Coronavirus testing kits, says Dr. Sean Parsons, CEO of Ellume

Alexander Davis | ConsumerConnect

In a move to prevent further inaccurate information of its Coronavirus testing kits, Ellume, an Australian company that produces at-home COVID-19 test kits, is recalling several thousands of the kits because some have been shown to render false positives.

ConsumerConnect gathered the company said the recall involves 43 lots of the product.

Dr. Sean Parsons, Chief Executive Officer (CEO) of Ellume, disclosed that an internal investigation isolated the cause of the defect, and confirmed that this incidence of false positives is limited to specific lots of the testing kits.

Parsons also stated: “In response, we worked with the FDA (US Food and Drug Administration) to voluntarily remove affected Ellume tests from the market. “Importantly, the reliability of negative results is unaffected by this issue.”

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