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, PREGNANT, PREGNANT
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
- Thyroid TSH Test Kit
- Model numbers
- EAN: 7340221700567, SKU: A-TSH, Lot/Serial Number: All Lots, UDI-DI: None
- 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
This is a thyroid function test kit intended to measure TSH levels. Such tests are used to screen or monitor thyroid health, typically under a clinician's guidance.
Why This Is Dangerous
The device was distributed without FDA premarket approval or clearance, creating regulatory risk and potential safety concerns for patients relying on it.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
For patients, the recall means seeking alternatives for thyroid testing and coordinating with healthcare providers to ensure accurate results.
Practical Guidance
How to identify if yours is affected
- Check for model numbers: EAN 7340221700567 or SKU A-TSH.
- Verify lot/serial number status: All Lots are affected.
- Confirm distribution: Nationwide in the United States.
Where to find product info
Manufacturer communications and FDA recall page for Z-0752-2026.
What timeline to expect
Refunds or replacements, if offered, may take several weeks to be processed after verification.
If the manufacturer is unresponsive
- Escalate to consumer protection agencies if the company is slow to respond.
- Keep records of all communications.
- Consider filing a complaint with the FDA or your local health authority if necessary.
How to prevent similar issues
- Use only FDA-cleared or FDA-approved thyroid testing kits.
- Verify premarket clearance before purchasing diagnostic devices.
- Check recalls for medical devices before use in clinical or home settings.
Documentation advice
Save packaging, receipt, and correspondence. Photograph the device and any labels for evidence.
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Product Details
Model numbers: EAN 7340221700567; SKU: A-TSH; UDI-DI: None; Lot/Serial Number: All Lots Sold: United States nationwide Sold date: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Class II medical device
- PMA/ Premarket clearance missing
- All lots affected (Lot/Serial Number: All Lots)
- US nationwide distribution
- Recall date: 2025-11-03; Report date: 2025-12-10
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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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