FDA recall, , Moderate risk
Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes
Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes may cause false or inaccurate diagnostic results by lay persons.
Summary by Recall Canary from the FDA notice
What happened
Changchun Wancheng Bio-Electron Co., Ltd., of Changchun, China, recalled test strips and other tests, including Vivoo Vaginal pH Test, Vivoo Sodium Test, LH One Step Ovulation Test Device, Typhi/Para Typhi A Antigen, Male Fertility Sperm Test for Home Use, LotFancy Urinary Tract Infection Urine (UTI) Test Strips, Vivoo pH Test, and Exploro Highly Sensitive Male Fertility / Sperm Concentration Test, because they require a 510(k) and were distributed before they could be legally marketed to U.S. customers.
The devices may cause false or inaccurate diagnostic results by lay persons and lead to inappropriate medical intervention. The recall began November 22, 2025, and distribution was in the states of TX, GA, CA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your cassette affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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)- UDI-DI
- 2025062001
- 2025033101
- 2025080801
- 2025090844
- 2025042110
- 2025021001
- 2024032508
- 2024071602
- 2024102108
- 202403103
- 202504103
- 202505103
- 202403104
- 202504104
- 202505104
- 202501105
- Lot code
- URS-3N
- 03-30-2027
- 08-07-2027
- 09-07-2027
Vivoo Vaginal pH Test
- UDI-DI
- 2024032219
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
- UDI-DI
- 2024013123
- 2024013124
- 2024013119
- 2025051519
LH One Step Ovulation Test Device (Urine)
- UDI-DI
- 20251601
S. Typhi/Para Typhi A Antigen
- UDI-DI
- 20251601
Male Fertility Sperm Test for Home Use (Cassette)
- UDI-DI
- 20251601
Vivoo pH Test
- UDI-DI
- 2024013121
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- UDI-DI
- 2025033101
- 2025080801
- 2025090844
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
- UDI-DI
- 2024032508
- 2024071602
- 2024102108
- 2025043007
- 2024013122
Menopause Test Cassette (Urine)
- UDI-DI
- 20251601
Vivoo Protein Test
- UDI-DI
- 2024013122
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Texas, Georgia, California.
- Company
- Changchun Wancheng Bio-Electron Co., Ltd.Changchun, China
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97801
- Recall numbers
- Z-1257-2026 to Z-1267-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
