BEUDAMED
    FDA Enforcement Class II Ongoing

    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,

    Recall: Z-2034-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-2034-2024
    Event ID
    94261
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wondfo USA Co Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2024
    Initiation Date
    April 22, 2024
    Classification Date
    June 7, 2024
    Address
    545 Willowbrook Center Pkwy Ste B, N/A, Willowbrook, IL, 60527-8436, United States

    Description

    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,

    Reason

    Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

    Code Info

    part numbers and lot numbers are unknown

    Distribution

    US Nationwide distribution.

    Quantity

    N/A