FDA Medical Device Recalls (openFDA)
Cellex: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
- Recall number
- Z-2452-2021
- Recalling firm
- Cellex
- Product
- Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
- Status
- Open, Classified
- Initiated
- 2021-03-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- The kit does not have an emergency use authorization (EUA).
- Root cause
- Under Investigation by firm
- Action
- The recall was initiated via phone. The date the telephone calls were made is unknown but may have occurred late February, early March, 2021, based on the date returns started being made to the recalling firm. The firm issued their initial letters dated 6/15/2021 via email as a result of not having documentation of the phone calls. Later notifications were also issued or verbally discussed, with the latest notification occurring 8/20/2021.
- Quantity
- Approximately 44,821 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, TX, and WI.
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3014277758
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28