“Cellex qSARS-Cov-2 Antigen Test Recall: No Emergency Use Authorization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63178-cellex-qsars-cov-2-antigen-test-recall-no-emergency-use. Based on FDA recall #Z-2452-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2452-2021%22&limit=1).
The FDA announced on March 1, 2021, that Cellex voluntarily recalled approximately 44,821 Cellex qSARS-Cov-2 Antigen Rapid Test kits because they lacked an emergency use authorization. The agency stated the kits were distributed nationwide in California, Florida, Texas, and Wisconsin.
According to the FDA, the hazard is that the Cellex qSARS-Cov-2 Antigen Rapid Test kit does not have an emergency use authorization (EUA). The recall covers all lot numbers of the product submitted as EUA202955.
Context
GovInfoNow's records show other recent recalls of similar diagnostic products include a GET TESTED INTERNATIONAL AB Epstein-Barr Virus Test recalled on November 3, 2025, due to unapproved distribution and a QUCARE Total Cholesterol Test recall on April 2, 2026, for missing FDA clearance. Additional recent actions involve a GET TESTED HPV Antigen Test distributed without premarket approval on November 3, 2025.
How to tell if you have this one
Check for the product name 'Cellex qSARS-Cov-2 Antigen Rapid Test' with 25 tests per box. All lot numbers are affected, so all units are recalled.
Brand
Cellex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and quantity (25 tests per box) to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Texas, Wisconsin.
Recall timeline
FDA published this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2452-2021 (March 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2452-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.