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
- Chlamydia Test Kit
- Model numbers
- EAN: 7340221701663, SKU: A-ICH, 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
This is a chlamydia testing product marketed for diagnostic use. It is positioned for use in healthcare settings or by patients with appropriate guidance.
Why This Is Dangerous
The hazard arises from distribution without FDA premarket approval or clearance, which may compromise test validity and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Limited to 5 units, but it requires immediate action to prevent use and potential misdiagnosis while awaiting proper clearance.
Practical Guidance
How to identify if yours is affected
- Verify model numbers: EAN 7340221701663 and SKU A-ICH.
- Check for Lot/Serial numbers: All Lots.
- Confirm distribution was nationwide in the US.
Where to find product info
Model numbers and lot information are on the product packaging and accompanying documents.
What timeline to expect
No timeline provided for refunds or replacements; follow manufacturer instructions.
If the manufacturer is unresponsive
- Escalate to FDA’s consumer contact channels if the manufacturer is unresponsive.
- Consider filing a complaint with the FDA if you believe the recall is mishandled.
How to prevent similar issues
- Buy only FDA-cleared or FDA-approved diagnostic tests.
- Verify PMA/510(k) status before purchase.
- Purchase from reputable sources and request official clearance documentation.
Documentation advice
Keep packaging, receipts, and recall communications as records. Document dates and contacts with the manufacturer.
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Product Details
Model numbers and identifiers include EAN 7340221701663 and SKU A-ICH. UDI-DI is None. Lot/Serial Number: All Lots. Distribution was nationwide in the United States. Specific sale dates and price are not provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide US distribution
- Model: EAN 7340221701663; SKU A-ICH
- UDI-DI: None; Lot/Serial: All Lots
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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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