BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2452-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2452-2021
    Event ID
    88206
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cellex
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 22, 2021
    Initiation Date
    March 1, 2021
    Classification Date
    September 13, 2021
    Address
    507 Airport Blvd Ste 107, N/A, Morrisville, NC, 27560-8200, United States

    Description

    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).

    Code Info

    All lot numbers

    Distribution

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

    Quantity

    Approximately 44,821 kits