Ellume COVID-19 Home Test recall
Ellume COVID-19 Home Test
Why was Ellume COVID-19 Home Test recalled?
Due to a higher rate of false positive test results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Ellume COVID-19 Home Test
- Recalling firm
- ELLUME LTD
- Quantity
- 427,994 kits
- Distribution
- U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
- Recall date
- November 17, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)