Changchun, N/A, China
Changchun Wancheng Bio-Electron Co., Ltd. recalls
1 recall recorded since 2018, most recently on 22 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 November 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1262-2026, Z-1263-2026, Z-1265-2026, Z-1257-2026, Z-1261-2026, Z-1258-2026, Z-1264-2026, Z-1267-2026, Z-1259-2026, Z-1260-2026, Z-1266-2026
- Male Fertility Sperm Test for Home Use (Cassette)
- Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Vivoo Protein Test
- LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urin
- S. Typhi/Para Typhi A Antigen
- The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
- Vivoo pH Test
- Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
- and 3 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.