GET TESTED INTERNATIONAL AB recalled four units of its Organic Acids Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately and follow the manufacturer's 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 recall affects four units of the Organic Acids Test. It has distribution across the United States. The product details include EAN: 616612786951, SKU: E408, and applies to all lots.
The product was distributed without the necessary premarket approval or clearance. This can pose significant risks as the safety and efficacy of the device have not been established.
No specific incidents, injuries, or deaths related to this recall have been reported. The lack of regulatory approval raises concerns about potential risks.
Stop using the Organic Acids Test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB or consult your healthcare provider for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB or visit their website. Further details about the recall can be found at the FDA link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0792-2026.
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