HIGH

GET TESTED INTERNATIONAL AB Recalls Vitamin D-Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer instructions.

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

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 Vitamin D-Test is a medical device used to measure Vitamin D levels in patients. Consumers typically buy this product for health monitoring and to guide dietary or supplement decisions.

Why This Is Dangerous

The hazard arises from the distribution of the Vitamin D-Test without the required FDA premarket approval. Devices lacking this approval may not have undergone necessary safety and efficacy evaluations, posing potential risks to patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face inconvenience as they must stop using the device and seek alternatives for monitoring Vitamin D levels. There are no immediate injuries reported, but the recall raises significant safety concerns.

Practical Guidance

How to identify if yours is affected

  1. Check the model numbers on the device packaging or accompanying documents.
  2. Verify if your product EAN is 7340221700802 or SKU is A-VID.
  3. Confirm that your device is from GET TESTED INTERNATIONAL AB.

Where to find product info

You can find the EAN, SKU, and other identifiers on the product packaging or user manual.

What timeline to expect

4-6 weeks for refund processing or further instructions.

If the manufacturer is unresponsive

  • Document your communication attempts with the manufacturer.
  • Reach out to the FDA for assistance if the manufacturer does not respond.

How to prevent similar issues

  • Look for FDA approval when purchasing medical devices.
  • Research manufacturer credibility and product reviews.
  • Consult healthcare professionals for recommendations.

Documentation advice

Keep records of your purchase, any correspondence with GET TESTED INTERNATIONAL AB, and photographs of the device.

Product Details

The recall involves the Vitamin D-Test, identified by EAN: 7340221700802 and SKU: A-VID. It was distributed nationwide throughout the U.S. since its release. The quantity recalled is 1,557 units.

Key Facts

  • Recall date: November 3, 2025
  • Quantity: 1,557 units
  • Classification: Class II
  • Distribution: U.S. Nationwide

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 LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 7340221700802
SKU: A-VID
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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