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Recall Observatory FDA recall evidence

Device product

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

Z-1370-2026

December 31, 2025

Class II

Product summary

Firm
Medica Corporation
Event
Event 98315
Status
Ongoing
Classification
Class II
Quantity
1,578 units
Official record key
device-enforcement:Z-1370-2026

Official wording

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.

Code information: Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.