Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Gonorrhea Test Kit
- Model numbers
- EAN: 7340221701533, SKU: A-IGO, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- 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
A gonorrhea diagnostic test used to detect infection in clinical or point-of-care settings. Such tests guide treatment decisions if properly cleared and validated.
Why This Is Dangerous
The recall centers on distribution without FDA premarket approval or clearance, raising regulatory and safety concerns about validation and clearance status.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Immediate action is required to prevent use of potentially unregulated diagnostic tests and to avoid regulatory complications in clinical settings.
Practical Guidance
How to identify if yours is affected
- Check model numbers: EAN 7340221701533 and SKU A-IGO.
- Lot/Serial Number: All Lots.
- Verify that your device is part of the recalled batch by cross-checking the items in your facility.
Where to find product info
Refer to the FDA recall page for the product tabs with recall number Z-0738-2026.
What timeline to expect
If offered, refunds or replacements will follow manufacturer processing times, typically 4-8 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to FDA or appropriate authorities if the company is unresponsive.
How to prevent similar issues
- Before purchasing diagnostic tests, verify FDA premarket clearance or approval.
- Buy from reputable sources and check labeling and recall history.
Documentation advice
Keep the recall letter, product 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
Model numbers: EAN 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: US nationwide distribution. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 463 units recalled nationwide
- All lots affected (Lot/Serial Number: All Lots)
- Model: EAN 7340221701533; SKU: A-IGO
- FDA recall number Z-0738-2026
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.