HIGH

GET TESTED INTERNATIONAL AB HbA1c Diabetes Test Recall Expands Nationwide (2025)

100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately and follow the manufacturer’s recall instructions.

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

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

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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

  1. Check if you own the GET TESTED INTERNATIONAL AB HbA1c Diabetes Test using EAN 7340221707191 or SKU A-HbA1c.
  2. Confirm all lots are affected since Lot/Serial Number: All Lots is stated.
  3. 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.

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

  • 148 units recalled
  • US nationwide distribution
  • Recall number Z-0732-2026 (FDA enforcement)
  • Model numbers: EAN 7340221707191; SKU A-HbA1c
  • Lot/Serial Number: All Lots

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
EAN: 7340221707191
SKU: A-HbA1c
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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