FDAHealthDecember 19, 2025
Altruan GmbH — Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
⚠️ Product not cleared by the FDA.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
US Nationwide distribution.
What's affected?
- Product
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- Brand
- Altruan GmbH
- Lot code
- 6933289812337
Additional details
Model No. 41972; No UDI; Lot Code: 6933289812337.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 188 units.
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