Drug recall
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
FDA recall event 88206 · Class II · Cellex
Key facts
| Event ID | 88206 |
|---|---|
| Recall numbers | Z-2452-2021 |
| Recalling firm | Cellex |
| Product type | Devices |
| Products | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The kit does not have an emergency use authorization (EUA). |
| Initiation date | Mar 1, 2021 |
| Report date | Sep 22, 2021 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 3014277758 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: