Cellex: Medical Device Recall in 2021 - (Recall #: Z-2452-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 1, 2021

Date Posted: September 22, 2021

Recall Number: Z-2452-2021

Event ID: 88206

Reason for Recall:

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

Status: Ongoing

Product Quantity: Approximately 44,821 kits

Code Information:

All lot numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated