Class IIReported 2026-03-18

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Recalled by Altruan GmbH

Reason for Recall

Product not cleared by the FDA.

Recall Number

Z-1560-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-03-18

Distribution

US Nationwide distribution.

Code Info

Model No. SP-C310343-10; No UDI; Lot Code: 01242573.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.