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

Company

Cellex

Recall Initiated

March 1, 2021

Recall Number

Z-2452-2021

Quantity

Approximately 44,821 kits

Firm Location

Morrisville, NC

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.

Lot / Code Info

All lot numbers

Root Cause

Under Investigation by firm

Action Taken

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.