Cellex qSARS-Cov-2 Antigen Rapid Test recall
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Why was Cellex qSARS-Cov-2 Antigen Rapid Test recalled?
The kit does not have an emergency use authorization (EUA).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbers
- Product
- Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
- Recalling firm
- Cellex
- Quantity
- Approximately 44,821 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, TX, and WI.
- Recall date
- September 22, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)