HIGH

GET TESTED INTERNATIONAL AB Intestinal Worms Test Recalled for 45 Units Nationwide in 2025

GET TESTED INTERNATIONAL AB recalled 45 intestinal worms test units distributed nationwide in the United States. The action follows distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.

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

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

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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. 1. Look for brand GET TESTED INTERNATIONAL AB on the device and packaging.
  2. 2. Check model numbers: EAN 616612785978 or SKU 2A169.
  3. 3. Confirm Lot/Serial Number: All Lots.
  4. 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.

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

  • 45 units recalled
  • Distributed nationwide in the US
  • Model numbers: EAN 616612785978; SKU 2A169
  • UDI-DI: None; Lot/Serial Number: All Lots
  • Recall status: ACTIVE

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 Product

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Safety Assessment

Risk LevelLOW
Severity Score
2/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
EAN: 616612785978
SKU: 2A169
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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