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
- Cholesterol Test Device
- Model numbers
- EAN 7340221704459, SKU DFI-CHT01
- 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
The cholesterol test device is marketed to measure cholesterol levels. It is distributed nationwide in the United States. Consumers may use it at home or with clinician guidance. The recall concerns regulatory clearance rather than device performance details.
Why This Is Dangerous
The hazard stems from distributing a medical device without required premarket approval or clearance. This creates a regulatory violation risk and potential questions about safety and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Consumers should stop using the device to avoid regulatory issues and ensure they follow manufacturer guidance for safe handling and disposal.
Practical Guidance
How to identify if yours is affected
- Check for model EAN 7340221704459 and SKU DFI-CHT01
- Confirm lot/serial number shows All Lots
- Verify purchase was in the United States and within the recall notice scope
Where to find product info
Look on the device label and packaging for model and SKU. The FDA enforcement report Z-0771-2026 contains recall details.
What timeline to expect
Refund or replacement timelines are not specified in the recall. Follow manufacturer instructions; processing timelines may vary.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- File a consumer complaint with the FDA if the manufacturer remains unresponsive
- Consider seeking guidance from a healthcare provider for alternatives to testing
How to prevent similar issues
- Only use FDA-cleared cholesterol testing devices.
- Verify device clearance before purchase.
- Ask healthcare providers for recommended testing alternatives if unsure about device clearance.
Documentation advice
Keep the recall letter, product packaging, model/SKU numbers, and any correspondence with the manufacturer for records.
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Product Details
Model numbers: EAN 7340221704459; SKU: DFI-CHT01. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Quantity: 80 units. Recall date: 2025-11-03. Status: Active. Manufacturer: GET TESTED INTERNATIONAL AB.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: EAN 7340221704459; SKU: DFI-CHT01
- All Lots affected
- Distributor: US nationwide
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Safety Guide
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