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
- Test Strips
- Model numbers
- Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)
- 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
The Vivoo Protein Test is a diagnostic tool used to measure protein levels in urine, which can indicate various health conditions. Consumers typically purchase this product for at-home health monitoring and to assist in managing health conditions.
Why This Is Dangerous
The Vivoo Protein Test may provide inaccurate results due to the lack of proper FDA approval, potentially leading to incorrect health assessments. This risk is especially concerning for individuals managing health conditions that require accurate monitoring.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face significant health risks if they rely on inaccurate results from the Vivoo Protein Test, leading to possible inappropriate medical interventions.
Practical Guidance
How to identify if yours is affected
- Check the packaging for the model name and lot number.
- Verify the expiration date, which should read January 30, 2026.
- Ensure the product was purchased from Texas, Georgia, or California.
Where to find product info
Look for the model name and expiration date on the box or the label of the test strips.
What timeline to expect
Expect processing for refunds to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your request and any communication attempts.
- Follow up with another call or email to the manufacturer.
- Consider reaching out to the FDA for further guidance.
How to prevent similar issues
- Always check for FDA approval on medical devices before purchasing.
- Research product reviews and safety records from reliable sources.
- Consult healthcare providers for recommendations on safe medical devices.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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Product Details
The recalled product is the Vivoo Protein Test, model name Vivoo Protein Test/2024013122, with an expiration date of January 30, 2026. The tests were distributed nationwide in the United States, specifically in Texas, Georgia, and California.
Key Facts
- Distributed in TX, GA, CA
- Model: Vivoo Protein Test/2024013122
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Safety Guide
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