Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- LOW
- 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
- Intestinal Worms Test Kit
- Model numbers
- EAN: 616612785978, SKU: 2A169, 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 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 Intestinal Worms Test is a diagnostic device intended to detect intestinal parasites. It is distributed nationwide in the United States.
Why This Is Dangerous
The hazard stems from distribution without premarket approval or clearance, a regulatory issue rather than a stated physical hazard.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects 45 units and requires immediate cessation of use. Consumers and healthcare providers should follow manufacturer instructions to address refunds or replacements.
Practical Guidance
How to identify if yours is affected
- 1. Look for brand GET TESTED INTERNATIONAL AB on the device and packaging.
- 2. Check model numbers: EAN 616612785978 or SKU 2A169.
- 3. Confirm Lot/Serial Number: All Lots.
- 4. If matched, stop use and contact the manufacturer for recall instructions.
Where to find product info
Recall details are on the FDA enforcement page linked in the citation and on the manufacturer’s recall notice.
What timeline to expect
Refund or replacement processing typically 4-6 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with FDA Consumer Safety and consult state consumer protection offices if needed.
How to prevent similar issues
- Only purchase medical devices from reputable channels.
- Check FDA recall databases before using a new diagnostic device.
- Verify premarket approval or clearance for diagnostic devices before distribution.
Documentation advice
Keep the recall notice, model and serial number information, and all communications with the manufacturer and healthcare providers.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Intestinal Worms Test Model numbers: EAN 616612785978; SKU 2A169; UDI-DI: None; Lot/Serial Number: All Lots Quantity recalled: 45 units Sold in: United States nationwide distribution Recall date: 2025-11-03 Status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed nationwide in the US
- Model numbers: EAN 616612785978; SKU 2A169
- UDI-DI: None; Lot/Serial Number: All Lots
- Recall status: ACTIVE
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Safety Guide
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