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
- Blood Type Test Kit
- Model numbers
- EAN: 7340221708136, SKU: A-BG
- 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
Blood Type Test is used to determine ABO and Rh type from a blood sample through in vitro testing. It is marketed for clinical or consumer use where typing is required.
Why This Is Dangerous
The recall is grounded in distribution without FDA premarket approval or clearance, reflecting regulatory noncompliance rather than a direct device failure.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Consumers may be using a device that lacks regulatory clearance, potentially affecting confidence in results and leading to replacement needs.
Practical Guidance
How to identify if yours is affected
- Look for model identifiers EAN 7340221708136 and SKU A-BG on the product label.
- Check Lot/Serial Number: All Lots are affected.
- Confirm distribution status: Nationwide in the United States.
Where to find product info
Label on the device, packaging, and the FDA recall page for Z-0728-2026.
What timeline to expect
Refund or replacement typically 4-8 weeks after claim submission.
If the manufacturer is unresponsive
- Document all communications with GET TESTED INTERNATIONAL AB.
- Escalate to FDA or local health authorities if there is no response.
How to prevent similar issues
- Only use FDA-cleared or FDA-approved medical devices.
- Verify premarket approval or clearance before purchase.
- Buy from reputable retailers and check recall status before use.
Documentation advice
Keep photos of the product and label, receipts, and all correspondence with the manufacturer.
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Product Details
Model numbers: EAN 7340221708136. SKU: A-BG. UDI-DI: None. Lot/Serial Number: All Lots. Distribution: US Nationwide. Sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers include EAN 7340221708136 and SKU A-BG
- Lot/Serial Number: All Lots
- Manufacturer: GET TESTED INTERNATIONAL AB
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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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