Recall Z-2452-2021— Cellex

Name: FDA recall Z-2452-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-01

Class II · Ongoing

Class II FDA medical device recall by Cellex, initiated 2021-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue". Reason: The kit does not have an emergency use authorization (EUA)..

Recalling firm: Cellex
Classification: Class II
Status: Ongoing
Initiated: 2021-03-01
Firm location: Morrisville, NC, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.