HIGH

GET TESTED INTERNATIONAL AB Recalls Pollen Allergy Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device 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
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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About This Product

The Pollen Allergy Test is designed for individuals to test for pollen allergies. Consumers typically purchase such tests to identify specific allergens and manage their symptoms effectively.

Why This Is Dangerous

The hazard stems from the lack of premarket approval, which means the product has not undergone necessary safety and efficacy evaluations. This raises concerns about its reliability and potential health risks during use.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires consumers to stop using the product immediately, which may cause inconvenience and necessitate seeking alternative testing methods.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the packaging or device.
  2. Verify if it matches EAN: 616612785688 or SKU: 1EP.
  3. Confirm if the product was purchased recently from a retailer.

Where to find product info

Model numbers can typically be found on the product packaging or instruction manual.

What timeline to expect

Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.

If the manufacturer is unresponsive

  • Follow up with GET TESTED INTERNATIONAL AB via phone or email.
  • Document your attempts to contact the company for records.

How to prevent similar issues

  • Always check for FDA approval before purchasing medical devices.
  • Look for established brands with a track record of safety compliance.
  • Read reviews and reports on medical devices before use.

Documentation advice

Keep records of your purchase, including receipts and correspondence with the manufacturer.

Product Details

The recalled Pollen Allergy Test has model numbers EAN: 616612785688 and SKU: 1EP. It was distributed nationwide in the U.S. All lots of the product are affected.

Key Facts

  • 10 units recalled
  • Distribution without premarket approval
  • Affected model: EAN: 616612785688
  • Affected model: SKU: 1EP
  • Stop using immediately

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
EAN: 616612785688
SKU: 1EP
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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