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
- Trichomonas Vaginalis diagnostic test
- Model numbers
- EAN: 7340221707245, SKU: A-ITV, 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
This is a Trichomonas vaginalis diagnostic test used to detect infections in patients and often employed by healthcare providers.
Why This Is Dangerous
The device was distributed without premarket approval or clearance, raising regulatory and safety concerns about verified efficacy and use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may be affected by access to an unapproved diagnostic test; the impact centers on regulatory noncompliance rather than shown clinical harm in the recall notice.
Practical Guidance
How to identify if yours is affected
- Check model numbers: EAN 7340221707245 and SKU A-ITV
- Verify lot/serial number information: All Lots
- Confirm it is the GET TESTED INTERNATIONAL AB Trichomonas Vaginalis test
- Review recall notices from the manufacturer and FDA
Where to find product info
FDA enforcement report Z-0753-2026 at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0753-2026
What timeline to expect
Refunds or replacements typically take several weeks depending on the manufacturer’s process
If the manufacturer is unresponsive
- Escalate to FDA recall contacts
- Consider reporting to the Federal Trade Commission if contact attempts fail
- Document all communications and follow up reminders
How to prevent similar issues
- Always verify that medical devices have premarket clearance or approval before purchase or use
- Only obtain devices from reputable sources and avoid unverified distributors
- Check the FDA recall database when acquiring diagnostic tests
- Watch for recall notices in your practice or pharmacy communications
Documentation advice
Keep a copy of the recall notice, record model/lot numbers, date of purchase, and all communications with the manufacturer
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Product Details
Model numbers: EAN 7340221707245, SKU A-ITV, UDI-DI None, Lot/Serial Number All Lots. Sold nationwide in the United States. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- All Lots affected
- US nationwide distribution
- Model numbers: EAN 7340221707245 and SKU A-ITV
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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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