Changchun Wancheng Bio-Electron Recalls Over 91,000 UTI and Urinalysis Test Strips Due to Inaccuracy Risk

FDA Recalls medium FDA · · United States

Changchun Wancheng Bio-Electron Co., Ltd. is recalling 91,366 urinalysis test strips across multiple brands because they were distributed without legal marketing authorization.

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary Class II recall of several brands of urinary tract infection (UTI) and urinalysis reagent strips. The recall was issued because the devices, which require a 510(k) clearance, were distributed to U.S. customers before they could be legally marketed. According to the FDA, these devices may produce false or inaccurate diagnostic results when used by laypersons, which could lead to inappropriate medical interventions.

Which Products Are Affected

A total of 91,366 units are affected by this recall. The products were distributed nationwide, specifically in Texas, Georgia, and California. Affected brands and lot numbers include:

  • LotFancy Urinary Tract Infection Urine (UTI) Test Strips: Lot 2025062001 (Exp: 06/19/2027)
  • LotFancy URS-3N Test Strip: Lots 2025033101, 2025080801, 2025090844
  • PALINOIA UTI-10 Parameter Reagent Strips: Lots 2025042110, 2025021001
  • Vaunn Medical 8-in-1 Urinalysis Reagent Strip: Lots 2024032508, 2024071602, 2024102108
  • JNW Direct 4-in-1 UTI Urinalysis Test Strips: Lots 30D25WC, 02D25WC, 30E25WC, 10H24WC
  • Urinify STRENGTH: Lots 202403103-6, 202504103-6, 202505103-6, 202504103-3, 202505103-3
  • Urinify ESSENTIAL: Lots 202403104-6, 202504104-6, 202505104-6, 202504104-3, 202505104-3
  • Urinify Urinary Tract Infection (UTI): Lot 202501105-5

What You Should Do

Consumers who have purchased these products should stop using them immediately. The firm initiated the recall via notification letters on November 22, 2025. Users should contact the place of purchase or the recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., for instructions regarding the disposal or return of the affected test strips.

Why This Matters

The use of unauthorized medical diagnostic tools poses a risk of incorrect self-diagnosis. Inaccurate results could cause a consumer to seek unnecessary medical treatment or fail to seek necessary care for a legitimate health condition.

Source

Information provided by the FDA under recall number Z-1257-2026.

Source: FDA Official Notice

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