Altruan GmbH
Device Recalls (Class II)
Class II
Z-1559-2026
·
20260318
·
Ongoing
Product
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.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API