Changchun Wancheng Bio-Electron Co., Ltd.: Device Recall

Recall Details

Recall Number

Z-1259-2026

Classification

Class II

Product Type

Device

Recalling Firm

Changchun Wancheng Bio-Electron Co., Ltd.

Status

Ongoing

Date Initiated

11/22/2025

Location

Changchun, N/A, China

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,000

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.

Product Description

LH One Step Ovulation Test Device (Urine)

Distribution Pattern

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

Other Recalls by Changchun Wancheng Bio-Electron Co., Ltd.

• Class II: Risk 11/22/2025
  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: Risk 11/22/2025
  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: Risk 11/22/2025
  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: Risk 11/22/2025
  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: Risk 11/22/2025
  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.

View all recalls by Changchun Wancheng Bio-Electron Co., Ltd. →