Cellex Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Brand
Cellex
Lot Codes / Batch Numbers
All lot numbers
Products Sold
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Cellex is recalling Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" due to The kit does not have an emergency use authorization (EUA).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The kit does not have an emergency use authorization (EUA).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026