← FDA ENFORCEMENT
Z-0759-2026Class II
GET TESTED INTERNATIONAL AB
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
GET TESTED INTERNATIONAL AB
Product type
Device
Status
Ongoing
Report date
2025-12-10
Distribution
US Nationwide distribution.
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Distribution without premarket approval/clearance.
Product description
Food Allergy Panel Test (IgE)
Code / lot info
EAN: 7340221709157; SKU: U44; UDI-DI: None; Lot/Serial Number: All Lots;
Other recalls SPEQ maps to Documentation & Change Control
2026-10-21Class IIIn2bones USA, LLC2026-10-21Class IIW L Gore & Associates, Inc.2026-10-21Class IIEthicon, LLC2026-10-21Class IIBoston Scientific Corporation
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →