Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- DHEA Test Kit
- Model numbers
- EAN: 616612786418, SKU: O320, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- 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
The DHEA Test is a diagnostic device used to measure dehydroepiandrosterone levels. It is intended for clinical or at least provider-use rather than consumer use. The recall concerns regulatory noncompliance rather than a reported defect in device performance.
Why This Is Dangerous
Distribution without FDA premarket approval or clearance raises safety and regulatory concerns. Use of an unapproved device could affect clinical decision-making.
Industry Context
This recall is not necessarily indicative of a broader industry pattern.
Real-World Impact
Healthcare providers and patients may be uncertain about the legitimacy and approval status of the test, which could delay appropriate care or lead to reliance on unapproved tests.
Practical Guidance
How to identify if yours is affected
- Check model numbers: EAN 616612786418 and SKU O320.
- Confirm lot/serial numbers: All Lots.
- Verify UDI-DI status: None.
Where to find product info
Model numbers and lot/serial information are printed on the device packaging and accompanying documentation.
What timeline to expect
Refunds or replacements, if offered, will follow the manufacturer's process. No timeline is stated in the recall notice.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- If the company is slow to respond, file a complaint with the FDA and seek guidance from a healthcare provider.
How to prevent similar issues
- Only purchase tests that have FDA premarket approval or clearance for clinical use.
- Verify device approval status before using diagnostic tests.
- Request documentation of regulatory clearance from suppliers.
Documentation advice
Keep the recall notice, purchase receipts, packaging, and all communications with the manufacturer as records.
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Product Details
Model numbers: EAN 616612786418; SKU O320; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: United States nationwide. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Manufacturer: GET TESTED INTERNATIONAL AB
- Model numbers: EAN 616612786418; SKU O320
- No injuries reported
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Safety Guide
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