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
- Biological Age & Longevity Test
- Model numbers
- EAN: 616612786210, SKU: H612, 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 product is a Biological Age & Longevity Test device distributed nationwide in the United States. It is marketed to assess aging-related biomarkers.
Why This Is Dangerous
The hazard arises from distributing a medical device without the necessary premarket approval or clearance, which may affect safety and regulatory compliance.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Consumers may stop using the device and seek guidance from healthcare providers, with potential delays in obtaining validated testing results.
Practical Guidance
How to identify if yours is affected
- Verify model identifiers: EAN 616612786210 and SKU H612.
- Confirm all lots are included as per recall notice.
- Review packaging and any recall letter from the manufacturer.
Where to find product info
Check the FDA recall page Z-0774-2026 and the manufacturer communications for instructions.
What timeline to expect
Remedy processing or instructions may follow the recall notification by the manufacturer; no specific timeline is provided.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Consider filing a complaint with regulatory bodies if the company remains unreachable.
How to prevent similar issues
- Always verify regulatory clearance before distributing or purchasing medical devices.
- Use devices from reputable manufacturers with clear FDA or equivalent approvals.
- Keep copies of all recall communications for records.
Documentation advice
Save recall letter, product packaging, model identifiers, and correspondence with the manufacturer for future reference.
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Product Details
Model numbers / identifiers: EAN 616612786210; SKU H612; UDI-DI: None; Lot/Serial Number: All Lots. Quantity: 3 units. Sold nationwide in the United States. Recall date: 2025-11-03. Manufacturer: GET TESTED INTERNATIONAL AB. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot/Serial Number: All Lots
- Sold nationwide in the US
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Safety Guide
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