Z-1560-2026 Class II Ongoing
FDA device recall Z-1560-2026 was initiated by Altruan GmbH on December 19, 2025 and is designated Class II. Reason for recall: Product not cleared by the FDA. The recall status is ongoing. Affected quantity: 188 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.