Cellex Recall 88206
Description: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Cellex Recall 88206 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2452-2021 |
| Event ID | 88206 |
| Event Description | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, TX, and WI. |
| Quantity | Approximately 44,821 kits |
| Recall Reason | The kit does not have an emergency use authorization (EUA). |
| Device Classification | 20210922 |
| Device Code Info | All lot numbers |
| Center Classification Date | 20210913 |
| Recall Initiation Date | 20210301 |
| Recalling Firm | Cellex |
| Initial Notification | Telephone |
| Similar To |