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.
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Recall Number
Z-1370-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-31
Reported
2026-02-25
Distribution
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Code Info
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.