Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brands
- Wondfo, Altruan GmbH
- 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
- Wondfo, Altruan GmbH
- Product type
- Strep A At-Home Self-Test Kit
- Model numbers
- Model No. 41972, No UDI, Lot Code: 6933289812337
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product not cleared by the FDA.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Altruan GmbH or your healthcare provider for instructions. Notification method: Other
About This Product
This is an at-home test kit intended to detect group A Streptococcus bacteria. Consumers purchase it for rapid, at-home screening of strep infections.
Why This Is Dangerous
The product has not been cleared by the FDA. That clearance normally assesses safety and effectiveness for its intended use. Without clearance, test results may be unreliable.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
If the test yields inaccurate results, patients may delay treatment or undergo unnecessary antibiotic use, potentially harming health outcomes.
Practical Guidance
How to identify if yours is affected
- Check packaging for Model No. 41972
- Look for Lot Code 6933289812337
- Note the marking No UDI on the product
Where to find product info
Model, lot, and UDI information are typically located on the device packaging or label
What timeline to expect
The recall does not specify a refund timeline; consumers should contact the manufacturer for instructions
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- If the company is unresponsive, file a consumer complaint with the FDA
- Keep copies of the recall notice and any correspondence
How to prevent similar issues
- Use FDA-cleared at-home tests when available
- Verify clearance status before purchasing diagnostic tests
- Follow manufacturer instructions and consult a healthcare provider if results are unclear
Documentation advice
Retain the recall notice, packaging photos, receipts, and any correspondence with the manufacturer
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Product Details
- Model No. 41972 - No UDI - Lot Code: 6933289812337 - Sold nationwide in the United States - Quantity: 188 units - Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- FDA clearance issue noted
- Discontinued nationwide in the US
- Model No. 41972 and Lot 6933289812337 identified
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Safety Guide
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