Z-0183-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 17, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 427,994 kits
Product Description
Ellume COVID-19 Home Test
Reason for Recall
Due to a higher rate of false positive test results.
Distribution Pattern
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
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;