Cellex COVID-19 Antigen Test kits recalled for lacking FDA emergency use authorization
Cellex is recalling approximately 44,821 units of its qSARS-CoV-2 Antigen Rapid Test due to lack of FDA emergency use authorization. The test was distributed nationwide in California, Florida, Texas, and Wisconsin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves an unapproved diagnostic test marketed without FDA emergency use authorization, creating risk of unreliable test results that could affect medical decisions. No illnesses or injuries have been reported; the regulatory violation and potential for diagnostic error justify a High severity rating.
Plain-English summary
Cellex is recalling approximately 44,821 kits of the qSARS-CoV-2 Antigen Rapid Test (25 tests per box) due to lack of FDA emergency use authorization (EUA). The company submitted the test for EUA approval under application number EUA202955, but the FDA declined to issue the authorization.
The product was distributed nationwide in California, Florida, Texas, and Wisconsin. All lot numbers are affected by this recall.
Consumers who have purchased this test should stop using it and consider alternative diagnostic methods to determine COVID-19 status.
The recalled product
- Product
- Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
- Manufacturer
- Cellex
- Category
- Medical Device — Diagnostic Test
- Affected units
- 44,821
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
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