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Ellume, an Australian digital diagnostics company, is recalling at least 200,000 COVID-19 rapid home test kits following a remarkably high rate of false positives, according to a report on the matter.
Distributors have been instructed to halt distribution and immediately quarantine affected kits, Ellume said.
The Food and Drug Administration also issued an alert this week regarding testing in the United States.
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The recall will remove the large number of home test kits at a time of particularly high demand.
Ellume has apologized for the slippage, and CEO Sean Parsons said the company understands the importance of accurate test results as the pandemic still kills people.
“We understand that trust is essential to achieving our goal as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health. and to regain some control of their lives during this pandemic, ”Parsons said in a statement.
“To these people, I offer my sincere apologies – and our entire company apologies – for any stress or hardship they may have experienced due to a false positive result,” Parsons continued.
Retailers and distributors affected by the recall are notified, and those who have tested positive while using the kits are encouraged to take confirmatory testing, Ellume said.
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“You have my personal commitment which we have learned from this experience, we have put in place additional controls to make sure our product meets our high quality standards and we will do everything in our power to regain your trust “said Parsons.
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