Morrisville, NC, United States
Cellex recalls
1 recall recorded since 2018, most recently on 1 March 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 March 2021
- Reason
- The kit does not have an emergency use authorization (EUA).
- Distribution
- US Nationwide distribution in the states of CA, FL, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2452-2021
- Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.