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Cellex recalls Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

Recalled September 22, 2021 · FDA recall Z-2452-2021 · Cellex

Hazard
The kit does not have an emergency use authorization (EUA). · FDA Class II
Units
Approximately 44,821 kits
Sold at
US Nationwide distribution in the states of CA, FL, TX, and WI.

Description

The kit does not have an emergency use authorization (EUA).

Product
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Manufacturer(s)
Cellex

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Cellex recalls Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" | RecallWatchUSA