BEUDAMED
    FDA Recall Open, Classified

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    Recall: Z-0324-2023 · Initiated August 8, 2022

    Recall

    Recall Number
    Z-0324-2023
    Event Number
    91032
    Firm
    GS Biomark LLC
    FEI Number
    3024479668
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    August 8, 2022
    Posted
    November 29, 2022
    Address
    1120 116th Ave NE, Suite 102, Bellevue, WA, 98004

    Description

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    Reason

    Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.

    Action

    On 08/08/2022, GS Biomark emailed customer to notify them that their COVID test kits - CoViPoint COVID test kit (MultiPLEX/Direct) have expired and to destroy unused material that they still have on-hand. Customer were not informed that the affected products did not have Emergency Use Authorization to distributed the product within the U.S.

    Distribution

    U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None

    Quantity

    639,200 kits