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 Candida Test is a medical device used to identify Candida infections. Patients and healthcare providers typically use it to diagnose fungal infections and determine appropriate treatments.
The distribution of the Candida Test without FDA premarket approval means it has not undergone the necessary evaluations to ensure its safety and effectiveness for medical use.
This recall is not part of a broader industry pattern.
Consumers who have purchased the Candida Test face potential health risks due to the lack of regulatory approval. Immediate cessation of use is required to avoid misdiagnosis or improper treatment.
You can find model numbers and lot numbers on the product packaging or instruction manual.
Expect a refund or replacement processing timeline of 4-6 weeks after returning the product.
Keep records of your purchase, including receipts and correspondence with the manufacturer regarding the recall.
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.
Not sure what to do next? Our guide walks you through the process step by step.
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