FDA Device recall Z-0183-2022
Ellume COVID-19 Home Test
- FDA Device
- Class I
- ongoing
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class I recall of Ellume COVID-19 Home Test by Ellume, citing due to a higher rate of false positive test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0183-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-10-01 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ellume |
| Distribution | MN, NY, PA, RI, UT, WA |
Product
Ellume COVID-19 Home Test
Reason
Due to a higher rate of false positive test results.
Identifiers
| code_info | Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1;…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0183-2022%22
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