Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal i...
FDA Recall #Z-1559-2026 — Class II — December 19, 2025
Product Description
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Reason for Recall
Product not cleared by the FDA.
Recalling Firm
Altruan GmbH — Massing, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
188 units
Distribution
US Nationwide distribution.
Code Information
Model No. 41972; No UDI; Lot Code: 6933289812337.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated