GET TESTED INTERNATIONAL AB recalled 528 syphilis test units on November 3, 2025. The recall follows the distribution of the test without necessary premarket approval. Patients and healthcare providers should 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 recalled syphilis test includes all lots under the model numbers EAN: 7340221701656 and SKU: A-ISY. The tests were distributed nationwide in the United States.
The product was distributed without the required premarket approval or clearance. This violation poses a high risk as the product may not meet safety and effectiveness standards.
No specific incidents or injuries have been reported related to this recall. The recall is proactive, addressing the lack of regulatory approval.
Patients and healthcare providers must stop using the recalled syphilis test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions on returning the product.
For more information, contact GET TESTED INTERNATIONAL AB. Visit their website or refer to the recall notification letter for detailed instructions.
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