FDAHealthDecember 19, 2025
Altruan GmbH — Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
⚠️ Product not cleared by the FDA.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
US Nationwide distribution.
What's affected?
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Brand
- Altruan GmbH
- Lot code
- 6952804827274
Additional details
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 188 units.
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