Cellex qSARS-Cov-2 Antigen Rapid Test — Class II medical device recall Z-2452-2021
Ongoing recall by Cellex, reported 2021-09-22, distributed nationwide. The kit does not have an emergency use authorization (EUA).
| Recall number | Z-2452-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cellex, Morrisville, NC, United States |
| Recall initiated | 2021-03-01 |
| Classified | 2021-09-13 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 44,821 kits |
Product
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Reason for recall
The kit does not have an emergency use authorization (EUA).
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-2452-2021. 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.