HIGH

GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

GET TESTED INTERNATIONAL AB recalled 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions 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, PREGNANT, PREGNANT

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

This is a thyroid function test kit intended to measure TSH levels. Such tests are used to screen or monitor thyroid health, typically under a clinician's guidance.

Why This Is Dangerous

The device was distributed without FDA premarket approval or clearance, creating regulatory risk and potential safety concerns for patients relying on it.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

For patients, the recall means seeking alternatives for thyroid testing and coordinating with healthcare providers to ensure accurate results.

Practical Guidance

How to identify if yours is affected

  1. Check for model numbers: EAN 7340221700567 or SKU A-TSH.
  2. Verify lot/serial number status: All Lots are affected.
  3. Confirm distribution: Nationwide in the United States.

Where to find product info

Manufacturer communications and FDA recall page for Z-0752-2026.

What timeline to expect

Refunds or replacements, if offered, may take several weeks to be processed after verification.

If the manufacturer is unresponsive

  • Escalate to consumer protection agencies if the company is slow to respond.
  • Keep records of all communications.
  • Consider filing a complaint with the FDA or your local health authority if necessary.

How to prevent similar issues

  • Use only FDA-cleared or FDA-approved thyroid testing kits.
  • Verify premarket clearance before purchasing diagnostic devices.
  • Check recalls for medical devices before use in clinical or home settings.

Documentation advice

Save packaging, receipt, and correspondence. Photograph the device and any labels for evidence.

Product Details

Model numbers: EAN 7340221700567; SKU: A-TSH; UDI-DI: None; Lot/Serial Number: All Lots Sold: United States nationwide Sold date: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1,916 units affected
  • Class II medical device
  • PMA/ Premarket clearance missing
  • All lots affected (Lot/Serial Number: All Lots)
  • US nationwide distribution
  • Recall date: 2025-11-03; Report date: 2025-12-10

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
6/ 10
Affected Groups
GENERALPREGNANTPREGNANTGENERAL
Injury Types
OTHER

Product Details

Model Numbers
EAN: 7340221700567
SKU: A-TSH
Lot/Serial Number: All Lots
UDI-DI: None
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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