GET TESTED INTERNATIONAL AB recalled 17 units of its DHEA Test on November 3, 2025. The recall resulted from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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The recall affects the DHEA Test with model numbers EAN: 616612786418 and SKU: O320. It includes all lots of the product. The device was distributed nationwide in the United States.
The device was distributed without obtaining the necessary premarket approval or clearance from regulatory authorities. This classification falls under Class II, indicating a moderate to high risk to patients.
There are no reported incidents or injuries associated with this recall. The absence of premarket approval raises concerns about the device's safety and efficacy.
Patients and healthcare providers should stop using the DHEA Test immediately. For further instructions, contact GET TESTED INTERNATIONAL AB or consult your healthcare provider.
For more details, visit the recall notification page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0776-2026.
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