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
- Kidney Test
- Model numbers
- EAN: 7340221701731, SKU: D-KID, 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
The Kidney Test is a diagnostic device marketed for kidney-related assessment. It is distributed nationwide in the United States through healthcare channels.
Why This Is Dangerous
The hazard stems from distributing a device without FDA premarket approval or clearance. This creates regulatory and safety concerns for users.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Up to 100 units were distributed with no reported injuries. The immediate risk is regulatory noncompliance and potential safety concerns for patients.
Practical Guidance
How to identify if yours is affected
- 1) Locate the model numbers: EAN 7340221701731 and SKU D-KID.
- 2) Check serial numbers: All Lots are affected.
- 3) Review recall communications mailed by the manufacturer.
Where to find product info
Labeling on the device, packaging, and the recall notice from the manufacturer. FDA recall page Z-0800-2026.
What timeline to expect
Typical refund or replacement timelines are not specified by the recall; providers recommend contacting the manufacturer for resolution.
If the manufacturer is unresponsive
- 1) Re-contact the manufacturer
- 2) File a complaint with the FDA’s Center for Devices and Radiological Health (CDRH) if there is no response within a reasonable timeframe
- 3) Document all communications and retain copies of the recall notification
How to prevent similar issues
- Verify regulatory clearance before purchasing diagnostic devices
- Ask healthcare providers to confirm FDA clearance for devices provided
- Check the FDA recall database prior to use and distribution of new devices
Documentation advice
Keep all recall notices, packaging, model numbers, and date codes; log communications with the manufacturer and healthcare providers.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Kidney Test Model numbers: EAN 7340221701731; SKU D-KID; UDI-DI None; Lot/Serial Number: All Lots Sold at: Nationwide distribution in the United States through healthcare providers Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Active recall as of 2025-12-10
- Hazard: Distribution without premarket approval/clearance
- Model numbers: EAN 7340221701731, SKU D-KID
- Distributor: Nationwide US distribution; no specific retailers listed
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Safety Guide
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