GET TESTED INTERNATIONAL AB: Medical Device Recall in 2025 - (Recall #: Z-0775-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Candida Test

Product Classification:

Class II

Date Initiated: November 3, 2025

Date Posted: December 10, 2025

Recall Number: Z-0775-2026

Event ID: 97896

Reason for Recall:

Distribution without premarket approval/clearance.

Status: Ongoing

Product Quantity: 109 units

Code Information:

EAN: 616612785916; SKU: 2A120; UDI-DI: None; Lot/Serial Number: All Lots;

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated