UPDATE: Nov. 10, 2021: FDA on Wednesday labeled Ellume's COVID-19 Home Test recall a Class I event due to the potential for false positive results. The agency last month issued a safety communication but it now warns that "use of these tests may cause serious adverse health consequences or death."

FDA's latest update said there have been 35 reports of false positive results but no deaths reported. Ellume has identified additional affected lots since last month's FDA update. The agency now pegs the number of recalled diagnostics in the U.S. at more than 2.2 million devices.

Dive Brief:

• Ellume is recalling certain lots of its at-home COVID-19 antigen test after discovering they are prone to giving false positive results, according to an FDA safety communication issued on Tuesday.
• The recall affects 17 master lots sent to retailers and the Department of Defense, which gave Ellume a $231 million contract earlier this year. Ellume has identified a manufacturing issue as the cause of the false positives and responded by implementing "additional controls" to address the problem. FDA said negative results do not appear to be affected by the manufacturing issue and that the agency is working with Ellume to assess the company’s "checks and other corrective steps" to ensure the problem is resolved.
• Work is underway to pull the affected products from store shelves and to quarantine stocks in the supply chain. The removal of the tests comes as the U.S. races to boost access to rapid COVID-19 antigen tests amid supply shortages.

Dive Insight:

Australia's Ellume broke new ground late last year when it became the first company to receive emergency use authorization from FDA for a fully at-home COVID-19 test that could be bought over the counter without a prescription. Ellume received a $30 million NIH contract to develop the test, and went on to land a $231 million DoD deal in February 2021 to scale up production and provide 8.5 million tests.  

Four of the recalled lots went to DoD, with the remaining tests being sent to retailers. Ellume is now taking the kits out of circulation because they deliver a higher rate of false positive results than was seen during clinical testing. Ellume received EUA on the strength of a study that saw its test deliver five false positives and 35 true positives. 

Full details of the manufacturing issue underlying the false positives are yet to emerge, but having implemented additional controls, Ellume has restarted distribution. Yet, the impact of the affected lots is still being felt. Ellume has asked consumers who bought affected tests to complete a form to request replacement kits. 

FDA in Tuesday's safety communication advised people who received positive results yet to be confirmed with a molecular test to contact their healthcare provider. The agency is asking people with positive, unconfirmed tests not to assume they had COVID-19 or have immunity against the coronavirus. People in that situation should discuss next steps with their healthcare provider. 

The recall will also remove rapid antigen tests from the nation's supply at a time when the Biden administration is trying to double the number of kits that are available. FDA gave a boost to the effort this week when it granted an EUA to Acon Laboratories' Flowflex COVID-19 Home Test.

Acon is aiming to increase output to 100 million tests a month by the end of the year and 200 million a month by February. FDA contends the addition of the kits to the supply chain will double U.S. rapid at-home testing capacity within weeks.