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
- Lyme Disease Test Kit
- Model numbers
- EAN: 7340221700468, SKU: A-ILY
- 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
Lyme Test devices are used to aid in diagnosing Lyme disease by detecting antibodies or pathogen markers in patient samples.
Why This Is Dangerous
Because the product was distributed without FDA premarket approval or clearance, there is a risk that the device’s accuracy and reliability have not been validated, potentially affecting diagnoses.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare providers and patients may experience delays or inaccuracies in Lyme disease diagnosis while awaiting cleared alternatives.
Practical Guidance
How to identify if yours is affected
- 1) Look for EAN 7340221700468 on the packaging
- 2) Look for SKU A-ILY on the device label
- 3) Confirm that the lot/serial number states All Lots
- 4) Cross-check with the recall notice from FDA/Manufacturer
Where to find product info
Recall notices are posted by the manufacturer and FDA enforcement reports. Check the recall URL in official channels.
What timeline to expect
Refund or replacement processing typically 4-6 weeks after submission of required information.
If the manufacturer is unresponsive
- File a consumer complaint with FDA/FTC if the company is unresponsive
- Document all communications and dates
- Consider contacting a healthcare professional for interim testing options
How to prevent similar issues
- Verify FDA clearance before purchasing any diagnostic tests
- Check for recall notices on FDA or company websites
- Only use tests from manufacturers with clear regulatory approvals
Documentation advice
Keep the recall notice, purchase records, test results, and all communications with the manufacturer and healthcare providers
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Product Details
Model numbers: EAN 7340221700468, SKU A-ILY. UDI-DI: None. Lot/Serial Number: All Lots. Sold in: US nationwide distribution. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 7340221700468, SKU: A-ILY
- Distributed nationwide in the US
- Hazard: distribution without FDA 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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