Medical device recalls Moderate risk

GET TESTED INTERNATIONAL AB recalls Diabetes HbA1c Test

Recall date
November 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0732-2026
FDA classification
Class II
Brand / firm
GET TESTED INTERNATIONAL AB
Sold / distributed
US Nationwide distribution.

Why it was recalled

Distribution without premarket approval/clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Diabetes HbA1c Test

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