Ellume, an Australian company that develops and manufactures diagnostic and other healthcare-related products, published a list on its website of the lot numbers on the packages of around 427,000 at-home test kits. Of those kits, only 195,000 remain unsold.
The company says it is working to email customers who have used one of the sold test kits and received a positive result to warn them that the tests are providing false-positive results at a rate higher than what researchers were shown during clinical trials.
Ellume is recommending people who have not scheduled another test to confirm their results to do so immediately. The Food and Drug Administration (FDA) followed this up on Tuesday with a separate statement urging people who received positive test results from Ellume tests to contact their trust care providers or proceed to an urgent care location and ask for a molecular diagnostic test to confirm the results. (Related: FDA document admits "covid" PCR test was developed without isolated covid samples for test calibration, effectively admitting it's testing something else.)
"I offer my sincere apologies – and the apologies of our entire company – for the stress or difficulties people may have experienced due to a false-positive result," says Ellume CEO Sean Parsons in a statement.
Around 18 percent of the affected test kits produced positive results. It isn't clear how many of those tests were positive. The faulty lots make up about 12 percent of the 3.5 million tests Ellume has already shipped to the U.S.
The problem with the tests is tied to manufacturing concerns and "is expected to be resolved with additional manufacturing checks and corrective actions," says FDA spokesman James McKinney.
"Manufacturing issues can arise with any medical device, including tests. This is one of the reasons why the FDA has a robust post-market surveillance program," adds McKinney.
The FDA first received complaints from Ellume customers regarding false positives in late August. McKinney says the FDA immediately went to work and investigate those concerns.
The FDA's online database regarding issues with medical devices lists just three reports about Ellume's tests in recent months. All three are about false-positive test results. One report says that a child had to miss several days of school because of a false positive. Another says that after getting a positive result from an Ellume test, a person subsequently got four negative test results from other COVID-19 tests.
Ellume's test kit is believed to be a game-changer. One at-home test kit comes with a nasal swab analyzer that customers can connect to an app on their smartphones. Test results can be provided within 15 minutes.
These test kits are the first such product to be authorized for widespread use by the FDA without requiring a prescription. The administration of President Joe Biden even invested around $232 million in expanding Ellume's production of the at-home test kits earlier this year.
The recall of the hundreds of thousands of at-home test kits is a huge setback for coronavirus screening using rapid tests like Ellume's. Experts think this will extinguish what little faith the American people have left in COVID-19 tests and the pandemic response of the Biden administration.
The White House is expected to announce a plan to purchase rapid at-home COVID-19 tests for $1 billion. This is on top of the $2 billion the federal government has already spent for similar rapid COVID-19 tests.
Learn more about how faulty and inaccurate COVID-19 tests are by reading the latest articles at Pandemic.news.