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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Mycoplasma Test
- Model numbers
- EAN: 7340221710030, SKU: A-MYC, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check your inventory for the Mycoplasma test, IgG and IgM by GET TESTED INTERNATIONAL AB.
- Verify the model numbers EAN: 7340221710030 and SKU: A-MYC to see if your test is affected.
- 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.
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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
- Class II recall
- Distribution without premarket approval
- Stop using immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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