Quick Facts at a Glance
- Recall Date
- November 22, 2025
- Hazard Level
- HIGH
- Brand
- Changchun Wancheng Bio-Electron Co.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Changchun Wancheng Bio-Electron Co.
- Product type
- Urinalysis Test Strips
- Model numbers
- 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) +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 22, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
Urinalysis test strips are commonly used to detect urinary tract infections and other health issues through urine samples. Consumers purchase these strips for convenient at-home testing and to avoid unnecessary doctor visits.
Why This Is Dangerous
The recalled test strips may produce false or inaccurate diagnostic results due to lack of proper FDA clearance. This can lead to misdiagnosis and inappropriate treatment, posing a significant health risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using these test strips may inadvertently misdiagnose a UTI or other medical condition, potentially leading to inappropriate medical treatments and further health complications.
Practical Guidance
How to identify if yours is affected
- Check the model number and expiration date on your test strips against the recall list.
- Verify if your test strips were sold in the affected states.
- Look for any communication from the manufacturer regarding the recall.
Where to find product info
Model numbers and expiration dates are typically located on the packaging or on the individual test strip containers.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Consider filing a complaint with the FDA if the manufacturer does not respond.
- Seek advice from a healthcare provider regarding any health concerns.
How to prevent similar issues
- Only purchase test strips that are FDA-cleared and approved.
- Check for recent recalls before using at-home medical tests.
- Consult with healthcare providers for recommendations on reliable products.
Documentation advice
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photographs of the product as evidence.
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Product Details
The recall affects 91,366 units of urinalysis test strips, including LotFancy Urinary Tract Infection Test Strips and others from brands like PALINOIA, Vaunn Medical, and JNW Direct. These products were distributed across the U.S., particularly in Texas, Georgia, and California. Models include LotFancy UTIs with expiration dates ranging from June 2026 to September 2027.
Key Facts
- Recall Date: November 22, 2025
- Distribution: Nationwide in the U.S.
- Quantity Recalled: 91,366 units
- Potential risk of false diagnostic results
- Affected models include LotFancy, PALINOIA, Vaunn Medical, and JNW Direct
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Safety Guide
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