FDA Medical Device Recalls (openFDA)
GET TESTED INTERNATIONAL AB: Food Sensitivity Test Medium
- Recall number
- Z-0761-2026
- Recalling firm
- GET TESTED INTERNATIONAL AB
- Product
- Food Sensitivity Test Medium
- Status
- Open, Classified
- Initiated
- 2025-11-03
- Posted
- 2025-12-01
- Terminated
- not on file
- Reason
- Distribution without premarket approval/clearance.
- Root cause
- No Marketing Application
- Action
- 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.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- EAN: 7340221709171; SKU: U144; UDI-DI: None; Lot/Serial Number: All Lots;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 3031995890
- Firm city
- Vastervik
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28