Class IIReported 2026-03-18

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Recalled by Altruan GmbH

Reason for Recall

Product not cleared by the FDA.

Recall Number

Z-1559-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-03-18

Distribution

US Nationwide distribution.

Code Info

Model No. 41972; No UDI; Lot Code: 6933289812337.

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