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

Recall Details

Recall Number

Z-1263-2026

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

4,800

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

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

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. →