GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all 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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D-Dimer tests measure a blood indicator used to assess clotting disorders. They are used in clinical settings to help evaluate suspected thrombotic conditions.
The recall concerns distribution of a diagnostic test kit without premarket approval or clearance, raising regulatory and reliability concerns rather than a known product defect.
This recall is not indicated as part of a broader industry pattern.
Healthcare providers may need to substitute FDA-cleared tests, causing potential delays in diagnosis and additional administrative steps.
Look on the kit packaging and instruction sheet for EAN, SKU, and lot information
No specific consumer refund timeline is provided. Follow manufacturer instructions and FDA updates.
Retain packaging, recall notices, and all communications with the manufacturer or healthcare providers for records
Model numbers: EAN 7340221700475; SKU A-CDM; UDI-DI: None; Lot/Serial Number: All Lots. Sold in the United States as part of nationwide distribution. Price: Unknown.
No injuries or incidents have been reported.
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