BEUDAMED
    FDA Recall Completed

    CovClear COVID-19 Rapid Antigen Test, ATG 900-031

    Recall: Z-0480-2022 · Initiated December 22, 2021

    Recall

    Recall Number
    Z-0480-2022
    Event Number
    89315
    Firm
    Empowered Diagnostics LLC
    FEI Number
    3017977164
    Product Code
    QKP
    Status
    Completed
    Root Cause
    No Marketing Application
    Initiated
    December 22, 2021
    Address
    3341 W Mcnab Rd, Pompano Beach, FL, 33069-4808

    Description

    CovClear COVID-19 Rapid Antigen Test, ATG 900-031

    Reason

    COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

    Action

    The firm notified their direct consignees by letter delivered by email on December 22, 2021. The letter explained the hazard and requested the discontinuation of use and distribution. Those who has further distributed the products, were requested to conduct a sub-recall.

    Distribution

    US Nationwide Distribution

    Quantity

    284,575 units