HIGH

GET TESTED INTERNATIONAL AB Female Fertility Test Recalled for Premarket Approval Violation (31Units

GET TESTED INTERNATIONAL AB recalled 31 Female Fertility Tests distributed nationwide in the US. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

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

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 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

  1. Check if you own a GET TESTED INTERNATIONAL AB Female Fertility Test.
  2. Note that all lots are affected according to the recall.
  3. 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.

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

  • 31 units recalled
  • Model numbers: EAN 7340221707139; SKU A-AMH; Lot: All Lots
  • Recall date: 2025-11-03
  • Status: ACTIVE
  • Hazard: Distribution without premarket approval/clearance
  • Remedy: Stop using; contact manufacturer for instructions

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 LevelLOW
Severity Score
3/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 7340221707139
SKU: A-AMH
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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