HIGH

GET TESTED INTERNATIONAL AB Issues Recall for Pet Allergy Test

GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units 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
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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Product Details

The recalled product is the Pet Allergy Test with model identifiers EAN: 616612785695, SKU: TI. It was distributed nationwide in the U.S. and is classified as a Class II medical device.

The Hazard

The recall stems from the distribution of the Pet Allergy Test without the necessary premarket approval or clearance. This lack of regulation may pose health risks to users.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The recall is precautionary due to the lack of regulatory approval.

What to Do

Patients and healthcare providers should stop using the Pet Allergy Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.

Contact Information

For more information, contact GET TESTED INTERNATIONAL AB. Visit their website or refer to the recall notice provided.

Key Facts

  • Recalled on November 3, 2025
  • 29 units affected
  • Distributed nationwide
  • Class II medical device
  • Stop using immediately

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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: 616612785695
SKU: TI
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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