Liver Test
Recall
- Recall Number
- Z-0801-2026
- Event Number
- 97896
- Firm
- GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden
- FEI Number
- 3031995890
- Product Code
- QWZ
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- November 3, 2025
- Posted
- December 1, 2025
Description
Liver Test
Distribution without premarket approval/clearance.
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.
US Nationwide distribution.
488 months