At-home COVID test maker Ellume is recalling tests after customers received false positive results.
43 lots distributed to retailers and distributors from April through August are included in the recall.
Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores.
Ellume recalled batches of its at-home coronavirus test kits, which are sold at Amazon, CVS, Target, Walmart, and Everlywell, due to a large number of reported falsely positive results.
The Australian-based test manufacturer said in a statement that the recall is limited to specific lots of tests and that "there is an increased chance that tests from the affected lot numbers may give a false positive result."
Tests from 43 lots sent to retailers and distributors between April and August were included in the recall.
There are approximately 427,000 tests in the recalled lots, a spokesperson from Ellume told Insider. In total, approximately 42,000 affected tests have been used and produced positive results, which include both true positives and false positives. 195,000 of the recalled tests are still unused.
The company is removing all affected products from retailers and is advising all customers to visit its website to see if their purchased test is included in the recall. Ellume will be reaching out to its customers who tested positive before September 17 to notify them that their results could have been incorrect, the company said.
The Food and Drug Administration said it's "working closely with Ellume to assess the company's additional manufacturing checks and other corrective steps to help ensure that the issue is resolved."
"At Ellume, we understand that trust is central to fulfilling our purpose 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 take back a bit of control of their lives during this pandemic," Sean Parsons, the company's founder and CEO, said in a statement.
Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. The rapid test kits provide results within 15 minutes and do not require a prescription. In clinical studies, Ellume tests were 96% accurate, according to data from the company.
In August, CVS had to limit the sale of Ellume's tests due to demand caused by the recent surge of the Delta variant across the US. The purchasing restraint was caused by manufacturing delays from suppliers of the tests, a CVS spokesperson previously told Insider.
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