Recall Z-1257-2026— Changchun Wancheng Bio-Electron Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Changchun Wancheng Bio-Electron Co., Ltd., initiated 2025-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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). 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..
- Recalling firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-22
- Firm location
- Changchun, N/A, China
Product description
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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.