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
- Diagnostic Test Device
- Model numbers
- EAN: 7340221709270, SKU: UNAD, UDI-DI: None, Lot/Serial Number: All Lots
- 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
NAD Profile Test appears to be a diagnostic device used in health and personal care. It is distributed nationwide in the United States and has a model listing including an EAN and SKU. The recall concerns regulatory compliance rather than an explicit product defect.
Why This Is Dangerous
The device was distributed without premarket approval or clearance. This regulatory issue could impact patient safety if the device were used in a clinical setting.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Consumers and healthcare providers must stop using the device and follow recall instructions. The impact is primarily regulatory risk and potential disruption to testing workflows.
Practical Guidance
How to identify if yours is affected
- Check the device labeling for EAN 7340221709270 and SKU UNAD
- Verify if any units were distributed within your facility or practice
- Refer to FDA notice for recall number Z-0766-2026
Where to find product info
FDA enforcement recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0766-2026
What timeline to expect
Remedies such as refunds or replacements may take weeks to months depending on manufacturer processes and regulatory approvals
If the manufacturer is unresponsive
- Escalate to manufacturer directly and document all communications
- If no response, file a complaint with CPSC or FDA as applicable for medical devices
How to prevent similar issues
- Require FDA clearance for device categories before purchase
- Verify premarket approval status with manufacturers
- Ask suppliers for official recall status and documentation
Documentation advice
Keep copies of recall notices, communications with manufacturer, purchase records, and any packaging labels.
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Product Details
Model numbers: EAN 7340221709270; SKU UNAD; UDI-DI: None; Lot/Serial Number: All Lots. Quantity recalled: 36 units. Distribution: US nationwide. Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model: EAN 7340221709270; SKU UNAD
- UDI-DI: None; Lot/Serial Number: All Lots
- Regulatory noncompliance: distribution without premarket approval/clearance
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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