Recall Record

Vastervik, Sweden

GET TESTED INTERNATIONAL AB recalls

1 recall recorded since 2018, most recently on 3 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
3 November 2025
Reason
Distribution without premarket approval/clearance.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0808-2026, Z-0756-2026, Z-0775-2026, Z-0767-2026, Z-0769-2026, Z-0804-2026, Z-0764-2026, Z-0733-2026, Z-0741-2026, Z-0750-2026, Z-0746-2026, Z-0793-2026 and 80 more

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.