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Altruan GmbH recalls Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Recalled March 18, 2026 · FDA recall Z-1561-2026 · Altruan
Hazard
Product not cleared by the FDA. · FDA Class II
Units
188 units
Sold at
US Nationwide distribution.
Description
Product not cleared by the FDA.
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Manufacturer(s)
Altruan GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →