Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- Recall date
- December 19, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1559-2026
- FDA classification
- Class II
- Brand / firm
- Altruan GmbH
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Product not cleared by the FDA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
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