medical Class II Updated 2026-02-11

Changchun Wancheng Bio-Electron Co., Ltd. recalls LotFancy Urinary Tract Infection Urine (UTI) Test Strips; P

Recalled 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)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Name/Lot(Expiration): LotFancy Urinary Tract Infection Urine (UTI) Test Strips/2025062001(06/19/2027); LotFancy URS-3N Test Strip/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027); PALINOIA UTI-10 PARAMETER REAGENT STRIPS/2025042110(04-20-2027), 2025021001(02-20-2027); Vaunn Medical 8-in-1 Urinalysis Reagent Strip/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); JNW Direct 4-in-1 UTl Urinalysis Test Strips/30D25WC(04/29/2027), 02D25WC(04/01/2027), 30E25WC(05/29/2027), 10H24WC(07/10/2026); Urinify STRENGTH/202403103-6(01/03/2026), 202504103-6(01/01/2027), 202505103-6(06/01/2027), 202504103-3(01/01/2027), 202505103-3(06/01/2027); Urinify ESSENTIAL/202403104-6(01/03/2026), 202504104-6(01/01/2027), 202505104-6(06/01/2027), 202504104-3(01/01/2027), 202505104-3(06/01/2027); Urinify Urinary Tract Infection (UTI)/202501105-5(01/02/2027)
View official government recall

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