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
- Diagnostic Test Kit
- Model numbers
- EAN: 7340221709300, SKU: UMT, 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
April 18, 2026
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 Mycotoxin Panel Test is a diagnostic test used to assess mycotoxin exposure. It is distributed by GET TESTED INTERNATIONAL AB in the United States.
Why This Is Dangerous
The hazard relates to distribution of a medical device without FDA premarket approval or clearance, which can mean the product may not have been evaluated for safety or effectiveness.
Industry Context
This recall is not indicated as part of a broader industry pattern in the data provided.
Real-World Impact
With only two units affected and nationwide distribution noted, consumer impact is limited but regulatory noncompliance poses safety and trust concerns for users.
Practical Guidance
How to identify if yours is affected
- Check for model numbers EAN 7340221709300 and SKU UMT
- Note that Lot/Serial Number applies to All Lots
- Confirm product name Mycotoxin Panel Test and brand GET TESTED INTERNATIONAL AB
Where to find product info
FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0765-2026
What timeline to expect
Not specified in the recall notice.
If the manufacturer is unresponsive
- Document all requests for instructions
- Escalate to FDA recall contacts if the manufacturer is unresponsive
- Consider filing a consumer complaint with the FDA if needed
How to prevent similar issues
- Only use FDA-cleared or FDA-approved diagnostic tests when applicable
- Verify regulatory clearance before purchasing medical devices
- Ask suppliers for proof of premarket approval or clearance
- Carefully review recall notices and manufacturer communications
Documentation advice
Keep the recall letter, packaging, model numbers, and any correspondence with the manufacturer for records.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Mycotoxin Panel Test Model numbers: EAN 7340221709300, SKU UMT UDI-DI: None Lot/Serial Number: All Lots Distribution: US Nationwide distribution Sold at: Unknown When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 7340221709300; SKU: UMT
- Lot/Serial Number: All Lots
- Hazard: Distribution without premarket approval/clearance
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Safety Guide
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