Changchun Wancheng Bio-Electron Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1258-2026 | Class II | The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Stri | November 22, 2025 |
| Z-1257-2026 | Class II | LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; | November 22, 2025 |
| Z-1264-2026 | Class II | Vivoo pH Test | November 22, 2025 |
| Z-1260-2026 | Class II | Menopause Test Cassette (Urine) | November 22, 2025 |
| Z-1263-2026 | Class II | Exploro Highly Sensitive Male Fertility / Sperm Concentration Test | November 22, 2025 |
| Z-1262-2026 | Class II | Male Fertility Sperm Test for Home Use (Cassette) | November 22, 2025 |
| Z-1265-2026 | Class II | Vivoo Protein Test | November 22, 2025 |
| Z-1261-2026 | Class II | S. Typhi/Para Typhi A Antigen | November 22, 2025 |
| Z-1267-2026 | Class II | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test | November 22, 2025 |
| Z-1259-2026 | Class II | LH One Step Ovulation Test Device (Urine) | November 22, 2025 |
| Z-1266-2026 | Class II | Vivoo Vaginal pH Test | November 22, 2025 |