Z-2452-2021Class II

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

Name: Z-2452-2021 Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Creator: Cellex
Published: 2021-03-01
License: https://open.fda.gov/license/

Cellex / initiated 2021-03-01 / Open, Classified

FDA source

Cellex began a recall of Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" on 2021-03-01. FDA classified it as Class II and gives the reason as "The kit does not have an emergency use authorization (EUA)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2452-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-01
Posted: 2021-09-13
Recalling firm: Cellex
Product: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: The kit does not have an emergency use authorization (EUA).
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: Approximately 44,821 kits
Distribution: US Nationwide distribution in the states of CA, FL, TX, and WI.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2452-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2452-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)