Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- 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
- GET TESTED INTERNATIONAL AB
- Product type
- Vitamin D2 and D3 Test Kit
- Model numbers
- EAN 7340221709232, SKU UD
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
Vitamin D2 and D3 tests are used by consumers to assess vitamin D levels. As an at-home or clinician-assisted diagnostic tool, accuracy and regulatory clearance are important for reliable results.
Why This Is Dangerous
Distribution without premarket approval/clearance means the device may lack FDA clearance and validated safety and effectiveness data. This raises concerns about the test’s reliability and regulatory compliance.
Industry Context
This recall is not described as part of a broader industry pattern in the information provided.
Real-World Impact
Individuals with vitamin D testing needs may face uncertainty about test results. Affected units should be removed from use to avoid potential misdiagnosis.
Practical Guidance
How to identify if yours is affected
- Check if you own a Vitamin D2 and D3 Test Kit from GET TESTED INTERNATIONAL AB.
- Verify model numbers: EAN 7340221709232 or SKU UD.
- Note Lot/Serial Number: All Lots.
Where to find product info
Label on the packaging and any recall notifications from GET TESTED INTERNATIONAL AB or FDA recall page.
What timeline to expect
Refunds or replacements are typically processed after the company issues a remedy. Consumers should expect follow-up instructions.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA if the company is unresponsive.
- Consider seeking guidance from healthcare providers on testing alternatives.
How to prevent similar issues
- Verify regulatory clearance before purchasing diagnostic tests.
- Choose tests from brands with FDA clearance or clear clinical validation.
- Keep records of recall communications and purchase receipts.
Documentation advice
Keep recall notices, photos of packaging and product, purchase records, and any correspondence with the manufacturer.
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Product Details
Model numbers: EAN 7340221709232 and SKU UD. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: GET TESTED INTERNATIONAL AB
- Product: Vitamin D2 and D3 Test Kit
- Hazard: Distribution without premarket approval/clearance
- Status: ACTIVE (Class II)
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Safety Guide
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