GET TESTED INTERNATIONAL AB recalls Gonorrhea test

Distribution without premarket approval/clearance.

Gonorrhea test

On November 3, 2025, MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: If you still have an unused test, it should not be used. You should render the kit unusable and discard the defaced components in accordance with ordinary household disposal practices and applicable local regulations. If your kit has already been used: You do not need to return used components. Please do not base medical decisions solely on that prior result and do not use any remaining units. If you have questions about your results or your health, consult your healthcare provider, who may recommend retesting using an FDA-authorized test that is appropriate for your situation. You may still contact us through the form for support or goodwill assistance regarding your order. Forwarding requirement for further distribution: If you further distributed the affected product(s) to other locations or customers, please immediately forward this notice to all downstream recipients and ensure they stop use/stop distribution, quarantine, and follow the disposition instructions.

• FDA enforcement recordOfficial FDA database entry for Z-0738-2026
• FDA device classification · JSXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GET TESTED INTERNATIONAL ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.