GET TESTED INTERNATIONAL AB recalled 658 units of its Parasite Test on November 3, 2025. The recall is due to distribution without premarket approval or clearance. Patients and healthcare providers should 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 recalled product includes all lots of the Parasite Test, identified by EAN: 7340221707153 and SKU: A-PARA. It has been distributed nationwide across the U.S. since its release.
The recall stems from the device being distributed without the necessary premarket approval or clearance. This poses a high risk to patients as the product may not meet safety and effectiveness standards.
No specific incidents or injuries have been reported related to this recall. The high hazard level indicates a significant risk due to lack of regulatory approval.
Patients and healthcare providers should stop using the Parasite Test immediately. Follow the recall instructions from the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further guidance.
For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0748-2026 or contact GET TESTED INTERNATIONAL AB directly.
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