Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- 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 Device
- Model numbers
- EAN: 7340221707153, SKU: A-PARA
- 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 18, 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 intended to aid in parasite detection. The recall concerns distribution without premarket clearance, which affects safety and regulatory compliance.
Why This Is Dangerous
There is a regulatory risk associated with distributing a device without required premarket approval or clearance. The data do not specify medical performance failures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers should halt use immediately. The recall focuses on regulatory noncompliance rather than an explicit medical failure in the provided information.
Practical Guidance
How to identify if yours is affected
- Check model identifiers: EAN 7340221707153
- Check SKU: A-PARA
- Verify Lot/Serial Number: All lots
- Review distribution statements for US nationwide coverage
Where to find product info
Model numbers are on packaging and device labels. The FDA recall page provides official instructions.
What timeline to expect
Refunds or replacements will be guided by the manufacturer and FDA notice timelines; expect several weeks to process after return approval.
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- Document all attempts to contact manufacturer
- Consider consumer protection channels if needed
How to prevent similar issues
- Require premarket clearance verification for medical devices before purchase
- Validate regulatory status with the manufacturer
- Rely on FDA recall notices for updates
Documentation advice
Keep copy of recall notice, model numbers, purchase documentation, and all communications
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: GET TESTED INTERNATIONAL AB. Product: Parasite Test. Model identifiers include EAN 7340221707153 and SKU A-PARA. Lot/Serial numbers: All lots. Quantity: 658 units. Distribution: US nationwide. Status: Active recall. Recall date: 2025-11-03. Report date: 2025-12-10.
Reported Incidents
No injuries or incidents have been reported in the data provided.
Key Facts
- 658 units recalled nationwide in the US
- Hazard: Distribution without premarket approval/clearance
- Model identifiers: EAN 7340221707153, SKU A-PARA
- Lot/Serial Number: All lots
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.