Cellex recalls 25-test antigen rapid tests due to lack of emergency use authorization. All units are affected. No remedy provided in official notice.
The kit does not have an emergency use authorization (EUA).
Cellex is recalling all 25-test antigen rapid tests because they were submitted for emergency use authorization but the authorization was denied. This means the tests are not approved for use and could be unsafe.
The tests lack emergency use authorization (EUA), which is a regulatory approval required for medical devices during emergencies. Without EUA, the tests may not work correctly or could pose health risks if used improperly.
Anyone who purchased the Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box. People using these tests for COVID-19 screening may be at risk due to unapproved status.
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.
Identify the product name and quantity (25 tests per box) to confirm if it matches the recalled item.
The product was submitted for emergency use authorization but the authorization was denied, meaning it is not approved for use.
The official notice does not provide a remedy, so no action is required beyond not using the product.
All units of the Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box are affected, so any product with this name and quantity is recalled.
We’ve drafted a message you can send Cellex to request your refund or repair — edit it as you like.
Subject: Recall Z-2452-2021 — Cellex Cellex Hello, I own a Cellex that is covered by recall Z-2452-2021 from Cellex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
