FDA-Device2026-02-25Class IIPROCESSING DEFECT
Medica capillary tubes recalled for falsely high potassium test results
What this means
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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-1370-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.