BEUDAMED
    FDA Enforcement Class I Completed

    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

    Recall: Z-0481-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0481-2022
    Event ID
    89315
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    Empowered Diagnostics LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 9, 2022
    Initiation Date
    December 22, 2021
    Classification Date
    January 28, 2022
    Address
    3341 W Mcnab Rd, N/A, Pompano Beach, FL, 33069-4808, United States

    Description

    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

    Reason

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

    Code Info

    all lots

    Distribution

    US Nationwide Distribution

    Quantity

    2100 units