HIGH

GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. 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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About This Product

The Mycoplasma test is designed to detect IgG and IgM antibodies associated with Mycoplasma infections. Consumers purchase this test to diagnose respiratory illnesses and other conditions caused by Mycoplasma bacteria.

Why This Is Dangerous

The hazard arises from the distribution of the test without premarket approval, meaning the product has not undergone the necessary regulatory scrutiny for safety and effectiveness. This could lead to inaccurate results and misdiagnosis.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects consumers who may have relied on this test for diagnosis. There is an urgent need to stop using the test due to safety concerns, which could lead to potential misdiagnosis.

Practical Guidance

How to identify if yours is affected

  1. Check your inventory for the Mycoplasma test, IgG and IgM by GET TESTED INTERNATIONAL AB.
  2. Verify the model numbers EAN: 7340221710030 and SKU: A-MYC to see if your test is affected.
  3. If you see the model numbers, your product is part of the recall.

Where to find product info

Model numbers can typically be found on the packaging or accompanying documentation of the test.

What timeline to expect

Expect an initial response from the manufacturer within 4-6 weeks regarding refunds or replacements.

If the manufacturer is unresponsive

  • Document all communication attempts with GET TESTED INTERNATIONAL AB.
  • Consider filing a complaint with the FDA if the company does not respond.

How to prevent similar issues

  • Look for FDA-approved tests when purchasing medical devices.
  • Check for premarket approval status before using diagnostic tests.
  • Stay informed about recalls in the medical device industry.

Documentation advice

Keep records of your purchase, any correspondence with the manufacturer, and notes on the recall for your personal records.

Product Details

The Mycoplasma test, IgG and IgM, has model numbers EAN: 7340221710030 and SKU: A-MYC. The product was distributed nationwide in the U.S. and has no specific price listed.

Key Facts

  • 23 units recalled
  • Class II recall
  • Distribution without premarket approval
  • 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 Classification

Product Details

Model Numbers
EAN: 7340221710030
SKU: A-MYC
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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