- Home COVID test maker Ellume is recalling tests after customers received false positive results.
- 43 lots distributed to retailers and distributors from April to August are included in the recall.
- Ellume was the first company approved by the FDA to sell COVID-19 test kits in stores.
Ellume recalled batches of its home test kits, which are sold on Amazon, CVS, Target, Walmart and Everlywell, due to a large number of falsely positive results reported.
The Australian-based test maker said in a statement that the recall is limited to certain lots of tests and that “there is an increased chance that tests from the affected batch numbers could give a false positive result.”
Tests from 43 batches sent to retailers and distributors between April and August were included in the recall.
Ellume did not indicate the number of tests included in the batches. The company did not immediately respond to Insider’s request for comment.
The company removes all affected products from retailers and advises all customers to visit its website to see if their purchased test is included in the recall. Ellume will contact its customers who tested positive before Sept. 17 to notify them that their results could have been incorrect, the company said.
The Food and Drug Administration said it “works closely with Ellume to assess the company’s additional production controls and other corrective steps to help ensure the issue is resolved.”
At Ellume, we understand that trust is central to fulfilling our purpose as a business, 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 take a little control back of their lives during this pandemic, “said Sean Parsons, the company’s founder and CEO, in a statement.
Ellume was the first company approved by the FDA to sell COVID-19 test kits in stores. The quick test kits give results within 15 minutes and require no prescription. In clinical trials, Ellume tests were 96% accurate according to company data.
In August, CVS had to limit sales of Ellume’s test due to demand caused by the recent increase in the Delta variant in the United States. The procurement restriction was caused by delays in production from suppliers of the tests, a CVS spokesman told Insider earlier.