Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
This recall is currently active, issued February 13, 2026. It was issued by Medica Corporation.
- Company
- Medica Corporation
- Recall Initiated
- December 31, 2025
- Posted
- February 13, 2026
- Recall Number
- Z-1370-2026
- Quantity
- 1,578 units
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Lot / Code Info
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Root Cause
Nonconforming Material/Component
Action Taken
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.