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
- Syphilis Diagnostic Test Kit
- Model numbers
- EAN 7340221701656, SKU A-ISY, 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 product is a syphilis diagnostic test kit intended for use in healthcare settings to screen for syphilis infections. It is distributed nationwide and used by clinicians to inform patient care decisions.
Why This Is Dangerous
The defect involves distribution without premarket approval or clearance. This means the product may not have demonstrated safety or effectiveness to regulatory standards, potentially affecting test accuracy and patient care.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Healthcare providers may need to halt use of the test and consult alternatives to avoid potential misdiagnosis and delayed treatment.
Practical Guidance
How to identify if yours is affected
- Identify GET TESTED INTERNATIONAL AB Syphilis Test with EAN 7340221701656 or SKU A-ISY.
- Verify lot/serial numbers are All Lots.
- Cross-check the FDA recall number Z-0751-2026.
Where to find product info
FDA enforceable recall page and official manufacturer communications
What timeline to expect
Refund or replacement processing commonly ranges from 4-8 weeks in recalls of this type
If the manufacturer is unresponsive
- File a complaint with FDA MedWatch if you experience issues or injuries
- Escalate with state consumer protection offices if the manufacturer is uncooperative
How to prevent similar issues
- Always verify FDA clearance status before purchasing medical diagnostic tests
- Rely on trusted retailers and check recall alerts for medical devices
- When in doubt, consult a healthcare professional before using diagnostic tests
Documentation advice
Keep copies of recall notices, packaging, model numbers, and all correspondence with the manufacturer
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: GET TESTED INTERNATIONAL AB; Product: Syphilis Test; Model numbers: EAN 7340221701656, SKU A-ISY; UDI-DI: None; Lot/Serial Number: All Lots; Sold nationwide in the United States; Recall date: 2025-11-03; Manufacturer: GET TESTED INTERNATIONAL AB; Price: Unknown; Quantity recalled: 528.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 528 units recalled nationwide in the US
- Model numbers: EAN 7340221701656 and SKU A-ISY
- Lot/Serial Number: All Lots
- FDA recall number: Z-0751-2026
- Remedy: Stop use and follow manufacturer instructions
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.