GET TESTED INTERNATIONAL AB recalled 27 PSA Test devices distributed nationwide in the United States on 2025-11-03 after regulators found the device was distributed without premarket approval or clearance. The lack of PMA/clearance means the device did not receive required regulatory authorization before sale. Patients and healthcare providers should stop using the device immediately and follow 제조
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 PSA Test device is used to measure prostate-specific antigen levels, typically as part of health assessments for men. It is distributed through healthcare settings.
The defect relates to regulatory approval. If the device is not PMA-cleared, its safety and efficacy have not been formally evaluated by regulators.
This recall is not described as part of a broader industry pattern in the provided notice.
Clinicians and patients may need to discontinue use and rely on alternative testing methods. The recall could affect ongoing diagnostic processes and scheduling.
Recall notice and FDA enforcement page linked in the source URL
Refunds or replacements typically arise within weeks depending on manufacturer processing and regulatory actions
Keep the recall notice, device labels showing model numbers, purchase receipts, and all correspondence with the manufacturer or healthcare providers
Model numbers include EAN 616612787316 and SKU G670D. UDI-DI is None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Manufacturer: GET TESTED INTERNATIONAL AB. Recall date: 2025-11-03. Quantity recalled: 27 units. Status: ACTIVE. URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0795-2026. Price not disclosed.
No injuries or incidents have been reported.
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