Recall Z-1370-2026 ยท CEM Electrode, Ion Specific, Potassium
Medica Corporation
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
| Date | Feb 13, 2026 (initiated Dec 31, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT FIELD SAFETY NOTICE was sent to consignees on 01/09/25 informing them that potassium results obtained using affected devices in capillary mode may be falsely elevated. The FSN instructed consignees not to report potassium results obtained in capillary mode using affected lots on the Easy Stat Analyzer. The FSN is to be forwarded to end users and to where product was further distributed. Consignees are to contact their local representative with any questions. |
| Quantity | 1,578 units |
| Distribution | International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021515 | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER Medica Corp., Jul 16, 2002 |