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
- Medical Diagnostic Device
- Model numbers
- EAN: 616612787187, SKU: 2A171, 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
Akkermansia Test is described as a diagnostic tool related to gut microbiome analysis from GET TESTED INTERNATIONAL AB.
Why This Is Dangerous
The hazard stems from distributing a medical device without required premarket approval, potentially affecting safety and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may be left with unusable results or delayed care if relying on this test; immediate action is required to prevent potential harm.
Practical Guidance
How to identify if yours is affected
- Look for EAN 616612787187 or SKU 2A171 on the product packaging
- Verify any Lot/Serial Number presence since All Lots are affected
- Confirm brand name GET TESTED INTERNATIONAL AB on the device
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0773-2026
What timeline to expect
Refunds or replacements, if offered, typically take 4-6 weeks after verification
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- File a complaint with the FDA if the manufacturer is non-responsive
- Consult a healthcare professional for alternatives or immediate testing needs
How to prevent similar issues
- Always check FDA clearance status before purchasing medical devices
- Look for clear labeling of regulatory status on packaging
- Ask providers about FDA-cleared alternatives when ordering diagnostic tests
- Keep copies of purchase receipts and recall notices
Documentation advice
Save the recall letter, FDA notice, and any correspondence with the manufacturer. Photograph packaging and serial numbers for your records
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Akkermansia Test Model numbers: EAN 616612787187; SKU 2A171; UDI-DI: None; Lot/Serial Number: All Lots Sold in: United States nationwide When sold: Unknown Price: Unknown Quantity: 24 units
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: EAN 616612787187; SKU 2A171
- All lots affected
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Safety Guide
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