Device product
Ellume COVID-19 Home Test
Z-0183-2022
Product summary
- Firm
- ELLUME LTD
- Event
- Event 88801
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 427,994 kits
- Official record key
device-enforcement:Z-0183-2022
Official wording
Reason: Due to a higher rate of false positive test results.
Code information: 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;
Distribution pattern: U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Derived failure modes
-
Unknown
Due to a higher rate of false positive test results.