Recall Z-1370-2026— Medica Corporation

Name: FDA recall Z-1370-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-31

Class II · Ongoing

Class II FDA medical device recall by Medica Corporation, initiated 2025-12-31. It names one FDA 510(k) clearance: K021515. Product: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-12-31
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K021515 — EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZERMedica Corp.·cleared 2002-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.