BEUDAMED
    FDA Enforcement Class I Ongoing

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    Recall: Z-1594-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1594-2023
    Event ID
    92137
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SD Biosensor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    March 31, 2023
    Classification Date
    May 23, 2023
    Address
    1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero, Suwon, N/A, N/A, Korea (the Republic of)

    Description

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    Reason

    The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

    Code Info

    Lot Numbers: 53K41T5T1 53K41X1T1 53K41X2T1 53K41X3T1 53K4211T1 53K4212T1 53K4213T1 53K4221T1 53K4222T1 53K4223T1 53K4224T1 53K4225T1 53K4231T1 53K4232T1 53K4233T1 53K4261T1 53K4262T1 53K4271T1 53K4272T1 53K4273T1 53K4274T1 53K4291T1 53K4292T1 53K42A1T1 53K42A2T1 53K42A3T1 53K42E1T1 53K42G1T1 53K42G2T1 53K42H1T1 53K42H2T1 53K42L1T1 53K42L2T1 53K4361AC 53K4362AC 53K4392AC 53K38N3T1 53K38N2T1 53K38N1T1 53K38N4T1 53K38N5T1 53K38P1T1 53K38P2T1 53K38P3T1

    Distribution

    US Nationwide.

    Quantity

    2,712,767 kits