GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided 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 Parasite Test was distributed nationwide in the United States. The recall affects all lots of the product with model numbers EAN: 616612786425, SKU: 2A178. The device was not approved for market distribution.
The product was distributed without the necessary premarket approval, posing potential risks to patients. Class II medical devices typically require regulatory clearance to ensure safety and effectiveness.
No specific incidents or injuries have been reported at this time. The potential risks are primarily related to the lack of regulatory approval.
Patients and healthcare providers should stop using the Parasite Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions regarding the recall.
For more information, contact GET TESTED INTERNATIONAL AB directly. Visit the FDA recall page for details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0793-2026.
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