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
- In vitro diagnostic test kit for organic acids
- Model numbers
- EAN: 616612786951, SKU: E408, 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 an in vitro diagnostic test kit intended to measure organic acids. It is marketed for clinical use and may be used by healthcare professionals to aid in diagnosis or monitoring. The recall concerns its distribution in the United States.
Why This Is Dangerous
The hazard stems from distributing a diagnostic device without FDA premarket approval or clearance. This raises concerns about regulatory compliance and product safety validation.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The immediate impact is regulatory risk for providers and patients. No injuries have been reported yet. Consumers must stop using the product and await instructions from the manufacturer.
Practical Guidance
How to identify if yours is affected
- Verify if you have the Organic acids Test kit labeled with EAN 616612786951 or SKU E408
- Confirm all lots are included
- Do not use the product if you own it
- Contact the manufacturer for recall instructions
- If refunds are offered, follow the manufacturer’s process
Where to find product info
Recall details and instructions are posted on the FDA enforcement report page. See https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0792-2026
What timeline to expect
No specific refund or replacement timeline is provided in the recall notice.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- File a complaint with FDA if the company is slow to respond
- Consult your healthcare provider for interim guidance
How to prevent similar issues
- Always check FDA clearance status before distributing diagnostic devices
- Verify device identifiers (EAN, SKU, Lot) before use
- Heed recall notices promptly and follow manufacturer instructions for returns or replacements
Documentation advice
Keep the recall notice, packaging, and any correspondence. Save receipts and dates of contact with the manufacturer.
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Product Details
Model numbers: EAN 616612786951; SKU E408; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: United States nationwide distribution. When sold: Recall date 2025-11-03. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Hazard: distribution without premarket approval/clearance
- Model identifiers: EAN 616612786951; SKU E408
- All lots affected
- Distribution: US nationwide
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Safety Guide
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