FDA Medical devices recall ·
Peptic Ulcer Test (H, pylori) recall
- Recall number
- Z-0794-2026
- Date
- (initiated November 3, 2025)
- Company / brand
- Get Tested International Ab
59334 Vastervik, Vastervik, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Peptic Ulcer Test (H, pylori)
Why was it recalled?
Distribution without premarket approval/clearance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
EAN: 616612787309; SKU: 2-B220; UDI-DI: None; Lot/Serial Number: All Lots;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0794-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.