Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Parasite Test
- Model numbers
- EAN: 616612786425, SKU: 2A178, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- 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 Parasite Test is a medical device used to detect parasitic infections. Consumers typically purchase these tests for home health monitoring or diagnostic purposes.
Why This Is Dangerous
The lack of premarket approval means that the device has not undergone necessary regulatory evaluations to ensure its safety and efficacy for consumers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face potential health risks by using an unapproved medical device. Immediate action is necessary to ensure safety.
Practical Guidance
How to identify if yours is affected
- Check if you have the Parasite Test with EAN: 616612786425 or SKU: 2A178.
- Verify the purchase date and source of the product.
- Consult the recall notice for further confirmation.
Where to find product info
Look for the EAN and SKU on the packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Consider filing a complaint with the FDA if issues persist.
- Seek legal advice if necessary.
How to prevent similar issues
- Always check for FDA approval before purchasing medical devices.
- Look for safety certifications like ISO or CE for medical products.
- Be cautious of home testing kits with limited regulatory oversight.
Documentation advice
Keep a copy of your purchase receipt and any correspondence with the manufacturer regarding the recall.
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Product Details
The Parasite Test was distributed nationwide in the United States. The recall affects all lots of the product with model numbers EAN: 616612786425, SKU: 2A178. The device was not approved for market distribution.
Key Facts
- Recall date: November 3, 2025
- Class II medical device
- Stop using the product immediately
- Contact manufacturer 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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