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GET TESTED INTERNATIONAL AB: GI Microbiome Profile XL

Medical DevicesSource: FDA (device) · Date: 2025-12-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GET TESTED INTERNATIONAL AB
Product
GI Microbiome Profile XL
Reason / hazard
Distribution without premarket approval/clearance.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-11-03
Code info
EAN: 7340221709225; SKU: UGXL; UDI-DI: None; Lot/Serial Number: All Lots;
Product quantity
3 units
Voluntary mandated
Voluntary: Firm initiated
City
Vastervik
Country
Sweden
Event id
97896
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