RecallDepth

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

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

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.

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