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
- MPOX diagnostic test device
- Model numbers
- EAN: 7340221708976, SKU: A-MPVAR, 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
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 MPOX Test is a diagnostic device intended to detect mpox infections. It is used in clinical or near-patient settings.
Why This Is Dangerous
The device was distributed without premarket approval or clearance, raising concerns about safety and effectiveness despite no reported injuries.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
The recall involves a small quantity and no reported injuries, but it underscores potential regulatory gaps in testing devices used for public health.
Practical Guidance
How to identify if yours is affected
- Check if your device matches EAN 7340221708976 or SKU A-MPVAR.
- Note that Lot/Serial Number is All Lots.
- Confirm the device was distributed in the United States.
Where to find product info
Look on the device packaging and label for EAN and SKU. See the FDA recall page for Z-0745-2026.
What timeline to expect
Recall processing and potential refunds or replacements may take 4-6 weeks.
If the manufacturer is unresponsive
- File a complaint with the FDA recall program if the manufacturer is unresponsive.
- Document all communication and keep receipts and photos.
How to prevent similar issues
- Only purchase FDA-authorized mpox diagnostic tests.
- Buy from reputable sources and verify clearance/approval before use.
- Watch for future recalls and confirm device clearance status at time of purchase.
Documentation advice
Save recall notice, packaging, model numbers, serial/lot information, and all correspondence with the manufacturer.
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Product Details
Brand: GET TESTED INTERNATIONAL AB. Product: MPOX Test diagnostic device. Model numbers: EAN 7340221708976; SKU A-MPVAR; UDI-DI: None; Lot/Serial Number: All Lots. Sold: Nationwide in the United States.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers: EAN 7340221708976, SKU A-MPVAR
- Lot/Serial Number: All Lots
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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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