United StatesLotFancy Urinary Tract Infection (UTI) Test Strips and multiple other urine, fertility, ovulation, menopause, antigen and home-test strips and devices manufactured by Changchun Wancheng Bio-Electron Co., Ltd. are included; affected items are identified by specific names, lot numbers and expiration dates listed in the FDA notice (for example LotFancy lot 2025062001 exp 06/19/2027). The products were recalled because they were distributed before required 510(k) clearance and may give false or inaccurate results, potentially leading to inappropriate medical intervention; affected devices were distributed nationwide in the U.S., including TX, GA and CA.
What's being recalled
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)
The 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 Test
LH One Step Ovulation Test Device (Urine)
Menopause Test Cassette (Urine)
S. Typhi/Para Typhi A Antigen
Male Fertility Sperm Test for Home Use (Cassette)
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Vivoo pH Test
Vivoo Protein Test
Vivoo Vaginal pH Test
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd., Changchun, N/A, China.
How to identify it
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) Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone Test/2024013122(01/30/2026) Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027) Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027) Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027) Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027) Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027) Name/Lot(Expiration): Vivoo pH Test/2024013121(01/30/2026) Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026) Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026) Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C…
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TX, GA, CA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)