GET TESTED INTERNATIONAL AB Trichomonas Vaginalis Test Recalled for Lack of Premarket Approval (2025

How to identify if yours is affected

1. Check model numbers: EAN 7340221707245 and SKU A-ITV
2. Verify lot/serial number information: All Lots
3. Confirm it is the GET TESTED INTERNATIONAL AB Trichomonas Vaginalis test
4. Review recall notices from the manufacturer and FDA

Where to find product info

FDA enforcement report Z-0753-2026 at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0753-2026

What timeline to expect

Refunds or replacements typically take several weeks depending on the manufacturer’s process

If the manufacturer is unresponsive

• Escalate to FDA recall contacts
• Consider reporting to the Federal Trade Commission if contact attempts fail
• Document all communications and follow up reminders

How to prevent similar issues

• Always verify that medical devices have premarket clearance or approval before purchase or use
• Only obtain devices from reputable sources and avoid unverified distributors
• Check the FDA recall database when acquiring diagnostic tests
• Watch for recall notices in your practice or pharmacy communications

Documentation advice

Keep a copy of the recall notice, record model/lot numbers, date of purchase, and all communications with the manufacturer