Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) ...
FDA Recall #Z-1560-2026 — Class II — December 19, 2025
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.
Recalling Firm
Altruan GmbH — Massing, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
188 units
Distribution
US Nationwide distribution.
Code Information
Model No. SP-C310343-10; No UDI; Lot Code: 01242573.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated