Medica recalled 1,578 units of its Capillary Tubes on December 31, 2025. A systematic positive bias of up to 20% can produce false elevation results in patient potassium levels. Healthcare providers and patients must stop using the device immediately.
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medica Corporation or your healthcare provider for instructions. Notification method: Letter
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The recall affects the EasyBloodGas/EasyStat Capillary Tube Kit, Model No. 7303. The product was distributed internationally to Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, and Belarus.
The capillary tubes may produce a systematic positive bias of up to 20% in potassium readings. This could lead to incorrect diagnosis and treatment, posing a serious health risk.
No specific incidents or injuries have been reported related to this recall. However, the potential for misdiagnosis remains a significant concern.
Stop using the capillary tubes immediately. Contact Medica Corporation or your healthcare provider for further instructions.
For more information, visit the Medica website or refer to the FDA recall notification at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1370-2026.
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