GET TESTED INTERNATIONAL AB's Lyme Test devices were distributed nationwide in the United States to healthcare providers. Regulators found the devices were distributed without FDA premarket approval or clearance. Healthcare providers and patients 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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Lyme Test devices are used to aid in diagnosing Lyme disease by detecting antibodies or pathogen markers in patient samples.
Because the product was distributed without FDA premarket approval or clearance, there is a risk that the device’s accuracy and reliability have not been validated, potentially affecting diagnoses.
This recall is not described as part of a broader industry pattern.
Healthcare providers and patients may experience delays or inaccuracies in Lyme disease diagnosis while awaiting cleared alternatives.
Recall notices are posted by the manufacturer and FDA enforcement reports. Check the recall URL in official channels.
Refund or replacement processing typically 4-6 weeks after submission of required information.
Keep the recall notice, purchase records, test results, and all communications with the manufacturer and healthcare providers
Model numbers: EAN 7340221700468, SKU A-ILY. UDI-DI: None. Lot/Serial Number: All Lots. Sold in: US nationwide distribution. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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