Ellume COVID-19 Home Test — Class I medical device recall Z-0183-2022
Ongoing recall by ELLUME LTD, reported 2021-11-17, distributed in MN, NY, PA, RI, UT, WA. Due to a higher rate of false positive test results.
| Recall number | Z-0183-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ELLUME LTD, East Brisbane, N/A, Australia |
| Recall initiated | 2021-10-01 |
| Classified | 2021-11-10 |
| Reported by FDA | 2021-11-17 |
| Distributed | MN, NY, PA, RI, UT, WA |
| Quantity | 427,994 kits |
| Lot numbers | 21047-4, 21047-5, 21089-1, 21099-1, 21117-1, 21124-1, 21125-1, PF03X-H, PF057-H, PF05W-H, PF069-H, PF06E-H, PF06N-H, PF06Z-H, PG080-H, PG08H-H, PH08X-H |
| Model numbers | I-SRS-C-01 |
Product
Ellume COVID-19 Home Test
Reason for recall
Due to a higher rate of false positive test results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0183-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.