PlainRecalls
FDA Devices Moderate Class II Ongoing

Kidney Test

Reported: December 10, 2025 Initiated: November 3, 2025 #Z-0800-2026

Product Description

Kidney Test

Reason for Recall

Distribution without premarket approval/clearance.

Details

Units Affected
100 units
Distribution
US Nationwide distribution.
Location
Vastervik

Frequently Asked Questions

What product was recalled?
Kidney Test. Recalled by GET TESTED INTERNATIONAL AB. Units affected: 100 units.
Why was this product recalled?
Distribution without premarket approval/clearance.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0800-2026.