Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Candida Test
- Model numbers
- EAN: 616612785916, SKU: 2A120, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check if you possess the Candida Test from GET TESTED INTERNATIONAL AB.
- Look for the model identifiers EAN: 616612785916 and SKU: 2A120 on the packaging.
- Verify if the device is within the recalled lots, which include all lots.
Where to find product info
You can find model numbers and lot numbers on the product packaging or instruction manual.
What timeline to expect
Expect a refund or replacement processing timeline of 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact GET TESTED INTERNATIONAL AB directly for further assistance.
- Document all communications and attempts to reach the company.
How to prevent similar issues
- Always verify FDA approval for medical devices before purchase.
- Research and choose brands with a strong safety record in medical devices.
- Consult healthcare professionals for recommendations on safe products.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer regarding the recall.
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Product Details
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.
Key Facts
- Distribution without premarket approval
- Stop using the device immediately
- Contact GET TESTED INTERNATIONAL AB for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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