Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- LOW
- 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
- Fertility Test Device
- Model numbers
- EAN: 7340221707139, SKU: A-AMH, 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
The product is a fertility testing device marketed to individuals to assess fertility status. It is sold in the Health & Personal Care category as a medical device.
Why This Is Dangerous
The issue stems from distribution without premarket approval/clearance, a regulatory violation rather than an immediate physical hazard.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers must stop using the device and follow manufacturer instructions. The recall involves 31 units, with no reported injuries, and may affect healthcare providers advising patients.
Practical Guidance
How to identify if yours is affected
- Check if you own a GET TESTED INTERNATIONAL AB Female Fertility Test.
- Note that all lots are affected according to the recall.
- Review recall notice for additional identifiers if provided.
Where to find product info
FDA enforcement page at the provided recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0737-2026
What timeline to expect
Manufacturer will provide further instructions. Refunds or replacements, if offered, typically follow company timelines communicated in recall notices
If the manufacturer is unresponsive
- Escalate to the FDA recall program if the company does not respond within a reasonable timeframe
- Maintain records of all communications and the recall notice
How to prevent similar issues
- Only purchase from reputable sources; check for FDA clearance or 510(k) status on medical devices
- Verify product identifiers (model, lot/serial) against recall notices
- Keep copies of recall communications and receipts for future reference
Documentation advice
Keep the recall notice, product packaging, purchase records, and all correspondence with the manufacturer.
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Product Details
Model numbers: EAN 7340221707139; SKU: A-AMH; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Recall date: 2025-11-03. Status: ACTIVE. Quantity: 31 units. Price: Unknown. Manufacturer: GET TESTED INTERNATIONAL AB.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 7340221707139; SKU A-AMH; Lot: All Lots
- Hazard: Distribution without premarket approval/clearance
- Remedy: Stop using; contact manufacturer for instructions
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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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