Z-1370-2026 Class II Ongoing

Recalled by Medica Corporation — Bedford, MA

Recall Details

Product Type
Devices
Report Date
February 25, 2026
Initiation Date
December 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,578 units

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.

Distribution Pattern

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

Code Information

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