Changchun Wancheng Bio-Electron Co., Ltd. recalls S. Typhi/Para Typhi A Antigen

Recall date

November 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1261-2026

FDA classification

Class II

Brand / firm

Changchun Wancheng Bio-Electron Co., Ltd.

Sold / distributed

US Nationwide distribution in the states of TX, GA, CA.

Why it was recalled

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

S. Typhi/Para Typhi A Antigen