GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without 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 sperm test is a medical device designed to assist in evaluating male fertility by analyzing sperm parameters. Consumers typically purchase this product for personal use or with the recommendation of healthcare providers to assess fertility issues.
The product's lack of premarket approval means it has not been adequately tested for safety and effectiveness. This raises significant concerns about its reliability and the potential risks associated with its use.
This recall is not part of a broader industry pattern.
Consumers must stop using the product immediately, which may cause inconvenience, particularly for individuals seeking fertility insights.
Look for the EAN or SKU numbers on the product packaging or user manual.
Expect a timeline of 4-6 weeks for possible refund processing following return instructions.
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
The recalled sperm test includes all lots under the brand GET TESTED INTERNATIONAL AB. It has been distributed nationwide across the United States. Specific model numbers include EAN: 7340221700444 and SKU: A-SPE.
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