Peptic Ulcer Test (H, pylori)
Reported: December 10, 2025 Initiated: November 3, 2025 #Z-0794-2026
Product Description
Peptic Ulcer Test (H, pylori)
Reason for Recall
Distribution without premarket approval/clearance.
Details
- Recalling Firm
- GET TESTED INTERNATIONAL AB
- Units Affected
- 12 units
- Distribution
- US Nationwide distribution.
- Location
- Vastervik
Frequently Asked Questions
What product was recalled? ▼
Peptic Ulcer Test (H, pylori). Recalled by GET TESTED INTERNATIONAL AB. Units affected: 12 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-0794-2026.
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