FDA Enforcement
Class II
Ongoing
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Recall: Z-1560-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1560-2026
- Event ID
- 98472
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Altruan GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- March 18, 2026
- Initiation Date
- December 19, 2025
- Classification Date
- March 12, 2026
- Address
- Morolding 6, N/A, Massing, N/A, N/A, Germany
Description
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Reason
Product not cleared by the FDA.
Code Info
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
Distribution
US Nationwide distribution.
Quantity
188 units