FDA recall Z-2452-2021

Product

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).

Distribution

US Nationwide distribution in the states of CA, FL, TX, and WI.

Key facts

Status

Ongoing

Initiation date

2021-03-01

Report date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2021