Allergy test Small

FDA device recall Z-0803-2026 · posted 2025-12-01 · Open, Classified

Recall details

Recalling firm

GET TESTED INTERNATIONAL AB

Reason for recall

Distribution without premarket approval/clearance.

Action taken

On November 3, 2025, MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: If you still have an unused test, it should not be used. You should render the kit unusable and discard the defaced components in accordance with ordinary household disposal practices and applicable local regulations. If your kit has already been used: You do not need to return used components. Please do not base medical decisions solely on that prior result and do not use any remaining units. If you have questions about your results or your health, consult your healthcare provider, who may recommend retesting using an FDA-authorized test that is appropriate for your situation. You may still contact us through the form for support or goodwill assistance regarding your order. Forwarding requirement for further distribution: If you further distributed the affected product(s) to other locations or customers, please immediately forward this notice to all downstream recipients and ensure they stop use/stop distribution, quarantine, and follow the disposition instructions.

Root cause

No Marketing Application

Status

Open, Classified

Product code

DHB

Quantity affected

19 units

Distribution

US Nationwide distribution.

Date initiated

2025-11-03

Date posted

2025-12-01

Location

Vastervik, Sweden