GET TESTED INTERNATIONAL AB recalled 60 units of its Trichomonas Vaginalis test on November 3, 2025. The recall follows distribution without proper 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 recalled product is the Trichomonas Vaginalis test by GET TESTED INTERNATIONAL AB. It has the following identifiers: EAN: 7340221707245, SKU: A-ITV, and applies to all lots. The product was distributed nationwide throughout the United States.
This recall stems from the distribution of the test without the necessary premarket approval or clearance. This lack of regulatory approval raises concerns about the product's safety and efficacy.
No specific incidents or injuries related to the use of the product have been reported. However, the FDA classified the hazard level as high due to the potential risks associated with unapproved medical devices.
Stop using the Trichomonas Vaginalis test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB. Contact your healthcare provider or the manufacturer for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB. Visit their website or call the customer service number provided in the recall notification letter.
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