Altruan GmbH
Altruan GmbH appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1561-2026, Class II) was initiated on December 19, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1561-2026 | Class II | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat | December 19, 2025 |
| Z-1559-2026 | Class II | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infe | December 19, 2025 |
| Z-1560-2026 | Class II | Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in | December 19, 2025 |