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
- Diagnostic Test Strips
- Model numbers
- Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)
- 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 S. Typhi/Para Typhi A Antigen test strips are used for diagnosing infections caused by the bacteria S. Typhi and Para Typhi. Consumers may use these strips for quick testing, particularly in near-patient settings.
Why This Is Dangerous
The test strips can produce false or inaccurate results, especially if used by individuals without medical training. Such inaccuracies can lead to incorrect diagnoses and treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks due to potential misdiagnosis from false results. This could lead to unnecessary treatments or delays in appropriate care.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for the model number GT-STA 20251601.
- Verify the expiration date of May 2027 on the test strips.
- Review any communication from your healthcare provider regarding the recall.
Where to find product info
The model number and expiration date can typically be found on the product box or label.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Always check for FDA clearance before purchasing diagnostic test strips.
- Look for certifications from recognized health authorities.
- Consult healthcare professionals for testing needs.
Documentation advice
Keep copies of receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the S. Typhi/Para Typhi A Antigen test strips, model GT-STA 20251601, with an expiration date of May 2027. These were distributed across Texas, Georgia, and California. The tests were not legally marketed in the U.S. before distribution.
Key Facts
- Recall date: November 22, 2025
- Quantity recalled: 1,000 units
- Affected states: TX, GA, CA
- Product expiration: May 2027
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.