GET TESTED INTERNATIONAL AB recalled 115 ferritin iron deficiency tests distributed nationwide in the United States. The tests were distributed without FDA premarket approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB or your healthcare provider for 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 ferritin iron deficiency test is intended to measure iron stores in a patient via a laboratory or diagnostic device. Such tests guide clinical decisions about iron supplementation or further testing.
Distributing a diagnostic device without FDA premarket approval or clearance may lead to unreliable results and inappropriate clinical decisions.
This recall is not part of a broader industry pattern.
The recall could affect patient care if unapproved tests yield inaccurate ferritin results. No injuries have been reported yet.
Model numbers and lot/serial information should appear on device packaging and accompanying documentation.
Timeline for refunds or replacements is not specified in the recall notice.
Keep the recall notice, packaging, photos of the device, model numbers, and any correspondence with the manufacturer.
Model numbers: EAN 616612785589; SKU 1FE; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown. Recall date: 2025-11-03. Report date: 2025-12-10.
No injuries or incidents have been reported.
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