GET TESTED INTERNATIONAL AB recalled 17 DHEA Test devices distributed nationwide in the United States after regulators flagged distribution without premarket approval. The devices lack FDA Premarket Approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall 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 DHEA Test is a diagnostic device used to measure dehydroepiandrosterone levels. It is intended for clinical or at least provider-use rather than consumer use. The recall concerns regulatory noncompliance rather than a reported defect in device performance.
Distribution without FDA premarket approval or clearance raises safety and regulatory concerns. Use of an unapproved device could affect clinical decision-making.
This recall is not necessarily indicative of a broader industry pattern.
Healthcare providers and patients may be uncertain about the legitimacy and approval status of the test, which could delay appropriate care or lead to reliance on unapproved tests.
Model numbers and lot/serial information are printed on the device packaging and accompanying documentation.
Refunds or replacements, if offered, will follow the manufacturer's process. No timeline is stated in the recall notice.
Keep the recall notice, purchase receipts, packaging, and all communications with the manufacturer as records.
Model numbers: EAN 616612786418; SKU O320; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: United States nationwide. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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