Class II
Medical Device Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Altruan GmbH · December 19, 2025
Reason for Recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
188 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1561-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.