Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in thro...
FDA Recall #Z-1561-2026 — Class II — December 19, 2025
Product Description
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.
Recalling Firm
Altruan GmbH — Massing, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
188 units
Distribution
US Nationwide distribution.
Code Information
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated