FDAHealthDecember 19, 2025
Altruan GmbH — Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
⚠️ 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
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
- Brand
- Altruan GmbH
- Lot code
- 01242573
Additional details
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 188 units.
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