GET TESTED INTERNATIONAL AB recalled 1,361 herpes tests on November 3, 2025. The recall stems from distribution without premarket approval. 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 recalled product is the Herpes (HSV-1 & HSV-2) Test. It is identified by EAN: 7340221710047 and SKU: A-HSV. The product was distributed nationwide in the U.S.
The herpes test was distributed without the necessary premarket approval or clearance. This lack of approval could lead to unreliable test results, posing health risks to patients.
No specific incidents or injuries have been reported related to this recall. The lack of approval raises concerns about potential false results.
Stop using the herpes test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB. Contact the manufacturer or your healthcare provider for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB or visit their website. Recall notifications will be sent via letter.
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