GET TESTED INTERNATIONAL AB recalled 754 units of its 2 in 1 Trichomonas / Gardnerella Test on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the product 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 2 in 1 Trichomonas / Gardnerella Test. The recall affects 754 units distributed nationwide in the U.S. It includes all lots of the product.
The product was distributed without the necessary premarket approval or clearance. This classification falls under Class II, indicating a moderate risk to users.
No specific incidents of injury or adverse effects have been reported related to this recall. However, the lack of approval raises concerns about safety and efficacy.
Patients and healthcare providers should stop using the 2 in 1 Trichomonas / Gardnerella Test immediately. Contact GET TESTED INTERNATIONAL AB or a healthcare provider for further instructions.
For more information, call GET TESTED INTERNATIONAL AB at the contact number provided in the recall notice. Visit the FDA website for details on the recall.
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