FDA-Device2026-02-25Class II
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Medica Corporation
Hazard
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.
Sold states
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Affected count
1,578 units
Manufactured in
5 Oak Park Dr, Bedford, MA, United States
Products
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1370-2026Original summary
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. 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. Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX. Distribution: International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus. Affected quantity: 1,578 units
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