FDA recall Z-1370-2026

Product

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

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

Key facts

Status

Ongoing

Initiation date

2025-12-31

Report date

2026-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1370-2026