Recall Z-1561-2026— Altruan GmbH

Name: FDA recall Z-1561-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by Altruan GmbH, initiated 2025-12-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.. Reason: Product not cleared by the FDA..

Recalling firm: Altruan GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Massing, N/A, Germany

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.