Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptoc
- Recalling company
- Altruan GmbH
- Product
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- Reason
- Product not cleared by the FDA.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 19, 2025
- Reported
- Mar 18, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 188 units
- Lot / codes
- Model No. 41972; No UDI; Lot Code: 6933289812337.
- Company location
- Massing, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1559-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1559-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.