GET TESTED INTERNATIONAL AB recalled 31 units of its Female Fertility Test on November 3, 2025. The product was distributed without required premarket approval or clearance. Users must stop using the device and follow the manufacturer's instructions.
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 Female Fertility Test includes all models under the brand GET TESTED INTERNATIONAL AB. It was distributed nationwide in the United States.
The recall is due to distribution of the device without premarket approval or clearance. This raises significant safety concerns regarding its efficacy and potential risks to users.
There are no reported incidents or injuries associated with the use of this product at this time. However, the lack of approval indicates potential risks.
Stop using the Female Fertility Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For more information, call GET TESTED INTERNATIONAL AB or refer to the recall letter sent to healthcare providers.
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