Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Reported: September 22, 2021 Initiated: March 1, 2021 #Z-2452-2021
Product Description
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).
Details
- Recalling Firm
- Cellex
- Units Affected
- Approximately 44,821 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, TX, and WI.
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue". Recalled by Cellex. Units affected: Approximately 44,821 kits.
Why was this product recalled? ▼
The kit does not have an emergency use authorization (EUA).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2452-2021.
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