GET TESTED INTERNATIONAL AB recalled 463 gonorrhea tests on November 3, 2025. The recall follows distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
Distribution without premarket approval/clearance.
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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The recall affects gonorrhea tests with EAN: 7340221701533 and SKU: A-IGO. The product was distributed nationwide in the United States. No price information is available.
The gonorrhea test was distributed without the necessary premarket approval or clearance from the FDA. This lack of regulatory oversight poses potential risks to patients and healthcare providers.
No injuries or incidents have been reported related to this recall. The recall is classified as Class II, indicating a high level of hazard.
Stop using the gonorrhea test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB. Contact your healthcare provider for further instructions.
Visit the FDA website for more information at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0738-2026.
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