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
- D-Dimer Test Kit
- Model numbers
- EAN: 7340221700475, SKU: A-CDM, UDI-DI: None, Lot/Serial Number: 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
D-Dimer tests measure a blood indicator used to assess clotting disorders. They are used in clinical settings to help evaluate suspected thrombotic conditions.
Why This Is Dangerous
The recall concerns distribution of a diagnostic test kit without premarket approval or clearance, raising regulatory and reliability concerns rather than a known product defect.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Healthcare providers may need to substitute FDA-cleared tests, causing potential delays in diagnosis and additional administrative steps.
Practical Guidance
How to identify if yours is affected
- Check the kit for EAN 7340221700475 and SKU A-CDM
- Confirm Lot/Serial Number is All Lots
- Verify that the kit was distributed in the US nationwide
Where to find product info
Look on the kit packaging and instruction sheet for EAN, SKU, and lot information
What timeline to expect
No specific consumer refund timeline is provided. Follow manufacturer instructions and FDA updates.
If the manufacturer is unresponsive
- File a consumer safety complaint with FDA if the manufacturer is unresponsive
- Consult your healthcare provider for guidance on testing alternatives
How to prevent similar issues
- Verify regulatory clearance before acquiring diagnostic tests
- Purchase only cleared/approved test kits from authorized suppliers
- Keep records of recall notices and correspondence
Documentation advice
Retain packaging, recall notices, and all communications with the manufacturer or healthcare providers for records
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Product Details
Model numbers: EAN 7340221700475; SKU A-CDM; UDI-DI: None; Lot/Serial Number: All Lots. Sold in the United States as part of nationwide distribution. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- D-Dimer Test kit
- Nationwide US distribution
- All lots affected
- Premarket approval missing
- 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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