Altruan GmbH recalls Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Recall date
- December 19, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1561-2026
- FDA classification
- Class II
- Brand / firm
- Altruan GmbH
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Product not cleared by the FDA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Get recall alerts
Free email alert whenever Altruan GmbH has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Altruan GmbH