GET TESTED INTERNATIONAL AB recalled 4 Organic acids Test kits distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow 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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This is an in vitro diagnostic test kit intended to measure organic acids. It is marketed for clinical use and may be used by healthcare professionals to aid in diagnosis or monitoring. The recall concerns its distribution in the United States.
The hazard stems from distributing a diagnostic device without FDA premarket approval or clearance. This raises concerns about regulatory compliance and product safety validation.
This recall is not described as part of a broader industry pattern.
The immediate impact is regulatory risk for providers and patients. No injuries have been reported yet. Consumers must stop using the product and await instructions from the manufacturer.
Recall details and instructions are posted on the FDA enforcement report page. See https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0792-2026
No specific refund or replacement timeline is provided in the recall notice.
Keep the recall notice, packaging, and any correspondence. Save receipts and dates of contact with the manufacturer.
Model numbers: EAN 616612786951; SKU E408; UDI-DI: None; Lot/Serial Number: All Lots. Where sold: United States nationwide distribution. When sold: Recall date 2025-11-03. Price: Unknown.
No injuries or incidents have been reported.
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