Changchun Wancheng

Vivoo urine test strips for sodium, vitamin C, and hydration were sold without required FDA approval and may provide false or inaccurate results. These tests are designed for home use and incorrect results could lead to unnecessary medical decisions. The affected products have specific lot numbers and expiration dates in 2026 and 2027.

Vivoo Vaginal pH Test strips were sold in the U.S. before receiving required FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical treatment based on incorrect information.

Vivoo Protein Test strips were sold in the U.S. before receiving required FDA approval. The tests may give false or inaccurate results, which could lead to unnecessary medical decisions based on incorrect information.

Vivoo pH Test strips were sold in the U.S. before receiving required FDA approval. The strips may give false or inaccurate results, which could lead to inappropriate medical decisions based on incorrect findings.

Exploro Highly Sensitive Male Fertility test strips were sold in the U.S. before receiving required FDA approval. These tests may give false or inaccurate results when used at home, potentially leading to unnecessary or inappropriate medical decisions.

Changchun Wancheng Bio-Electron Co., Ltd. distributed a home sperm fertility test kit without proper FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical decisions based on incorrect information.

Changchun Wancheng Bio-Electron distributed S. Typhi/Para Typhi A Antigen test strips in the U.S. before receiving required FDA approval. These test strips may produce false or inaccurate results when used by patients or untrained individuals, which could lead to wrong medical decisions.

Changchun Wancheng Bio-Electron distributed urine-based menopause test kits (lot GT-FSH 20251601) without required FDA approval. These tests may give false or inaccurate results, potentially leading to unnecessary medical treatment.

Changchun Wancheng Bio-Electron distributed LH One Step Ovulation Test strips in the U.S. without required FDA approval. The tests may give false or inaccurate results, which could lead to wrong medical decisions.

The FDA found that Girlfriend Doctor Dr. Anna Cabeca Keto-pH, URIMED Urinalysis Reagent Strips URS-5, and Vivoo Ketone test strips were sold without proper FDA approval. These tests can give false or inaccurate results, which may lead to wrong medical decisions.

Several brands of over-the-counter urinary tract infection test strips were sold in the U.S. without proper FDA approval. These strips may give false or inaccurate results, which could lead to wrong treatment decisions or missed infections.