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
- HbA1c Diabetes Test
- Model numbers
- EAN: 7340221707191, SKU: A-HbA1c
- 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 HbA1c Diabetes Test is a diagnostic tool intended to measure average blood glucose levels over several weeks. It is used by patients and healthcare providers to monitor diabetes management.
Why This Is Dangerous
Distribution without premarket approval or clearance means the device may not have demonstrated safety or effectiveness for its intended use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Consumers may have purchased or received this device under the assumption of regulatory clearance, potentially impacting medical decision-making.
Practical Guidance
How to identify if yours is affected
- Check if you own the GET TESTED INTERNATIONAL AB HbA1c Diabetes Test using EAN 7340221707191 or SKU A-HbA1c.
- Confirm all lots are affected since Lot/Serial Number: All Lots is stated.
- Verify UDI-DI status as None.
Where to find product info
Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0732-2026
What timeline to expect
Refunds or replacements may take 4-6 weeks after verification. Follow manufacturer instructions for processing.
If the manufacturer is unresponsive
- Document all contact attempts with GET TESTED INTERNATIONAL AB.
- If the company is slow, file a complaint with the FDA recall portal.
How to prevent similar issues
- Seek FDA-cleared or FDA-approved HbA1c testing options for home or clinical use.
- Verify regulatory clearance before purchasing diagnostic devices.
- Choose products from brands with clear FDA clearance and posted recall history.
Documentation advice
Keep recall notices, order confirmations, labeling, and correspondence. Photograph all packaging and serial numbers for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: EAN 7340221707191; SKU A-HbA1c. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Recall date: 2025-11-03. Report date: 2025-12-10. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Recall number Z-0732-2026 (FDA enforcement)
- Model numbers: EAN 7340221707191; SKU A-HbA1c
- Lot/Serial Number: All Lots
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.