HIGH

GET TESTED INTERNATIONAL AB Recalls Vitamin D2 and D3 Test

GET TESTED INTERNATIONAL AB recalled 10 units of its Vitamin D2 and D3 Test on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
November 3, 2025
Hazard Level
HIGH
Brand
GET TESTED INTERNATIONAL AB
Category
Health & Personal Care
Sold At
Unknown
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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Product Details

The recalled product is the Vitamin D2 and D3 Test, distributed nationwide across the U.S. It carries the model numbers EAN: 7340221709232, SKU: UD, and applies to all lots.

The Hazard

The recall stems from the product being distributed without the required premarket approval or clearance. This raises serious safety concerns regarding its use.

Reported Incidents

No specific incidents or injuries have been reported related to this recall as of the latest report.

What to Do

Stop using the device immediately. Follow the manufacturer’s recall instructions and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page or contact GET TESTED INTERNATIONAL AB directly. Detailed instructions are included in the notification letter.

Key Facts

  • Recall date: November 3, 2025
  • Class II recall status
  • 10 units recalled nationwide
  • Distribution without premarket approval

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 7340221709232
SKU: UD
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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