Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

FDA Recall #Z-1370-2026 — Class II — December 31, 2025

Recall #Z-1370-2026 Date: December 31, 2025 Classification: Class II Status: Ongoing

Product Description

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

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.

Recalling Firm

Medica Corporation — Bedford, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,578 units

Distribution

International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.

Code Information

Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated