BEUDAMED
    FDA Recall Open, Classified

    Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

    Recall: Z-1559-2026 · Initiated December 19, 2025

    Recall

    Recall Number
    Z-1559-2026
    Event Number
    98472
    Firm
    Altruan GmbH Morolding 6 Massing Germany
    FEI Number
    3042770115
    Product Code
    GTY
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    December 19, 2025
    Posted
    March 12, 2026

    Description

    Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

    Reason

    Product not cleared by the FDA.

    Action

    The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.

    Distribution

    US Nationwide distribution.

    Quantity

    188 units