GET TESTED INTERNATIONAL AB recalled 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices 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 HPV Antigen Test is a medical device used to detect the presence of human papillomavirus (HPV). Consumers typically purchase this test for screening purposes in a healthcare setting or at home.
The hazard arises from the distribution of the HPV Antigen Test without the necessary premarket approval, which raises concerns about its reliability and safety for consumer use.
This recall is not part of a broader industry pattern.
The recall affects the availability of HPV testing options for consumers, potentially leading to delays in necessary health screenings.
Model numbers and lot information can typically be found on the packaging or the product insert.
Refund processing typically takes 4-6 weeks after returning the product.
Keep records of your purchase, correspondence with the manufacturer, and any receipts or invoices as documentation.
The recalled product is the HPV Antigen Test, with model numbers including EAN: 7340221708259 and SKU: A-HPV. The recall affects all lots of this product. It was distributed nationwide in the United States.
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