FDA-Device2026-02-25Class IIPROCESSING DEFECT
Medica capillary tubes recalled for falsely high potassium test results
OTHERNationwide distribution
Stop using Medica capillary tubes
Medica Corporation's capillary tubes used with EasyBloodGas and EasyStat devices are giving false potassium results—up to 20% higher than actual levels. This could lead doctors to misinterpret a patient's potassium levels and provide incorrect treatment.
- Stop using Medica capillary tubes (Model 7303, Lot 25XXX)
- Contact Medica Corporation or your supplier for instructions on device return or replacement
- Notify your laboratory or healthcare facility of this recall
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-1370-2026Don't want to check this manually?
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