Medical device recalls Moderate risk

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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