Recall archive / FDA device enforcement
Ellume COVID-19 Home Test — FDA record Z-0183-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ellume COVID-19 Home Test
- Reason
- Due to a higher rate of false positive test results.
- Classification
- Class I
- Recalling firm
- ELLUME LTD
- Quantity
- 427,994 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0183-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 17, 2021
- Recall initiation date
- Oct 1, 2021
- Center classification date
- Nov 10, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.