FDA has issued a recall of Ellume COVID-19 Home Test, due to a higher rate of false positive test results.
How many units are recalled and why?
FDA has recalled 2 million units of Ellume COVID19 Home Test. This recall was due to a manufacturing defect.
How do I know if my purchased product is affected?
Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Compare the lot number to the recalled lot numbers listed below:
Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H;
What do I do if my purchase is affected?
Users that have used the affected products within the last two weeks are being informed and instructed to:
1. If they have received a positive test result, this result may be incorrect and they should contact a healthcare professional immediately and notify them of this recall and ask to obtain a confirmatory test (i.e., molecular or RT-PCR).
2. If they have already had a confirmatory test that confirms they DO have COVID-19, disregard this notice and follow their healthcare professional’s advice and CDC guidance on self-isolation,