Medica Corporation recalls Medica Capillary Tubes

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.

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1370-2026
• FDA 510(k) clearance · K021515The device's official FDA premarket clearance record
• FDA device classification · CEMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1600The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medica CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.