Medical Device

LH One Step Ovulation Test Device (Urine)

Recall date: 2026-02-11 · Source: FDA_DEVICE

Brand / Firm

Changchun Wancheng Bio-Electron Co., Ltd.

Product

Reason for recall

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.

Units affected

1,000

Description

LH One Step Ovulation Test Device (Urine)

View official recall notice →