(ABC4) – An at-home COVID-19 approved for emergency use by the U.S. Food and Drug Administration is being recalled amid an increased chance that tests could give a false-positive result.
Specific lots of Eullume’s rapid, at-home COVID-19 antigen test after they were found to have rates of false-positive tests higher than was observed in clinical testing. Ellume says it has identified the root cause of this issue and is implementing additional controls to resolve it.
Tests from the specific lots are now being recalled. If you have an impacted Ellume COVID-19 Home Tests – you can see the list of affected lot numbers below – you can request a replacement here. Affected home tests were distributed to retailers and distributors from April through August 2021.
If you do attempt to use an affected test, Ellume says you will be notified in the Ellume COVID-19 Home Test app that the test has been recalled and disabled. If you have used an affected test and received a positive result in the last 14 days, Ellume says it will notify you via email. If you have not already had a confirmatory test, you should get one.
Here are the affected lots, courtesy of Ellume.
|Master Lot Number||Final Kit Lot Number||Expiration Date|
|21047-4||21047-4||February 28, 2022|
|21047-5||21047-5||February 28, 2022|
|21089-1||21089-1||March 31, 2022|
|21099-1||21099-1 (USA)||March 31, 2022|
|21117-1||21117-1||April 30, 2022|
|21124-1||21124-1||March 31, 2022|
|21125-1||21125-1||April 30, 2022|
|PF03X-H||PF03W-H, PF03V-H, PF03S-H, PF03T-H||May 31, 2022|
|PF057-H||PG07T-H, PG07Q-H, PG082-H, PG07R-H, PG07S-H||May 31, 2022|
|PF05W-H||PF05M-H, PF05E-H, PF05Y-H, PF05H-H, PF05J-H||May 31, 2022|
|PF069-H||PF06J-H, PF06D-H, PF06B-H, PF06C-H||May 31, 2022|
|PF06E-H||PF06G-H, PF068-H, PF066-H, PF067-H||April 30, 2022|
|PF06N-H||PF06P-H, PF06R-H, PF06Q-H||May 31, 2022|
|PF06Z-H||PG07X-H, PF070-H, PG07Z-H, PF071-H, PG074-H||June 30, 2022|
|PG080-H||PG084-H, PG081-H||June 30, 2022|
|PG08H-H||PF065-H, PF060-H||May 31, 2022|
|PH08X-H||PH08Y-H||May 31, 2022|
For more details from Ellume, click here.