BEUDAMED
    FDA Enforcement Class II Ongoing

    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

    Recall: Z-2030-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-2030-2024
    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

    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

    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

    a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W03910902, W03911002, W03910911, W03921005, W03921102, W03921008, W039212001, W039212006, W03920804; b) PRE-STA-10, UDI/DI **, Lot Numbers: W03920902, W03921103, W039307002, W039306008, W03931002

    Distribution

    US Nationwide distribution.

    Quantity

    1,238,755 units