FDANovember 22, 2025device
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; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
changchun wancheng bio electronchangchunchangchun wancheng
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCCurtis International Expands Recall of Frigidaire-brand Minifridges Due to Fire and Burn Hazards2026-01-15
- FDAExploro Highly Sensitive Male Fertility / Sperm Concentration Test2025-11-22
- FDAMenopause Test Cassette (Urine)2025-11-22
- FDAVivoo Vaginal pH Test2025-11-22
- FDAThe 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 Test2025-11-22
- FDAMale Fertility Sperm Test for Home Use (Cassette)2025-11-22
- FDAS. Typhi/Para Typhi A Antigen2025-11-22
- FDAVivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test2025-11-22
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