Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
FDA Recall Z-1370-2026 · Posted 2026-02-13
Advertisement
Recalling FirmMedica Corporation
Recall StatusOpen, Classified
Product CodeCEM
Date Initiated2025-12-31
Product Quantity1,578 units
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement