Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue… — Class II medical device recall Z-0091-2025
Ongoing recall by CUE HEALTH INC, reported 2024-10-23, distributed nationwide. Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
| Recall number | Z-0091-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CUE HEALTH INC, San Diego, CA, United States |
| Recall initiated | 2024-05-24 |
| Classified | 2024-10-15 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Lot numbers | 30757C, 30760C, 30761G, 30762G, 30879C, 30882C, 30884G, 30885G, 30886G, 30889G, 30918C, 30923C, 30924C, 30926G, 31032G, 31033G, 31036G, 31037G, 31038B, 31040C, 31041C, 31042C, 31043C, 31044C, 31045C, 31046C, 31158C, 31161C, 31162C, 31163E, 31165B, 31166B, 31373E, 31374B, 31400B, 31403B, 31404B, 31408E, 31410E, 31464B and 15 more |
| Model numbers | 2900005, COVID-19 |
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Reason for recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
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-0091-2025. 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.