GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this 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 recalled product includes all lots of the Candida Test. It has model identifiers EAN: 616612785916 and SKU: 2A120. The device was distributed nationwide in the United States.
The Candida Test poses a high risk as it was distributed without the necessary premarket approval or clearance from the FDA. This lack of regulatory oversight means the device may not meet safety and efficacy standards.
No injuries or incidents have been reported related to the use of the Candida Test at this time. However, the lack of approval raises serious safety concerns.
Patients and healthcare providers should stop using the Candida Test immediately. They should follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or their healthcare provider for further instructions.
For more information, contact GET TESTED INTERNATIONAL AB. Visit the FDA's website for additional recall details.
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