Altruan GmbH
Device Recalls (Class II)
Class II
Z-1561-2026
·
20260318
·
Ongoing
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Reason for Recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API