COVID-19 home tests recalled over false-positive results

Coronavirus Updates

The Ellume COVID-19 Home Test. (Photo courtesy of Ellume)

(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 NumberFinal Kit Lot NumberExpiration Date
21047-421047-4February 28, 2022
21047-521047-5February 28, 2022
21089-121089-1March 31, 2022
21099-121099-1 (USA)March 31, 2022
21117-121117-1April 30, 2022
21124-121124-1March 31, 2022
21125-121125-1April 30, 2022
PF03X-HPF03W-H, PF03V-H, PF03S-H, PF03T-HMay 31, 2022
PF057-HPG07T-H, PG07Q-H, PG082-H, PG07R-H, PG07S-HMay 31, 2022
PF05W-HPF05M-H, PF05E-H, PF05Y-H, PF05H-H, PF05J-HMay 31, 2022
PF069-HPF06J-H, PF06D-H, PF06B-H, PF06C-HMay 31, 2022
PF06E-HPF06G-H, PF068-H, PF066-H, PF067-HApril 30, 2022
PF06N-HPF06P-H, PF06R-H, PF06Q-HMay 31, 2022
PF06Z-HPG07X-H, PF070-H, PG07Z-H, PF071-H, PG074-HJune 30, 2022
PG080-HPG084-H, PG081-HJune 30, 2022
PG08H-HPF065-H, PF060-HMay 31, 2022
PH08X-HPH08Y-HMay 31, 2022

For more details from Ellume, click here.

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