BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0324-2023
    Event ID
    91032
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GS Biomark LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2022
    Initiation Date
    August 8, 2022
    Classification Date
    November 29, 2022
    Address
    1120 116th Ave NE, Suite 102, Bellevue, WA, 98004, United States

    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.

    Code Info

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 110421005, 110121005, 62322004 BM-ADK0200 / 110121003 BM-CDK0200 / 110121004 BM-CFDK0200 / 110121006 BM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001 BM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002 BM-DK0600 / 110521002, 10722003, 12122004 BM-DK0800 / 12722006 BM-DK1200 / 120221002, 50222002 BM-DK1400 / 92421002, 101821005, 32222004 BM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001

    Distribution

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

    Quantity

    639,200 kits