FDA recall Z-1560-2026
Altruan GmbH · Class II · device
Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Reason for recall
Product not cleared by the FDA.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-12-19
- Report date
- 2026-03-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Massing, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1560-2026