[Recalled] Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" — The kit does not have an emergency use authorization (EUA) | FDA 2021-03-01
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" |
|---|---|
| Brand / manufacturer | Cellex |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2452-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 March 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The kit does not have an emergency use authorization (EUA).
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.