Z-1370-2026Class II

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit

Name: Z-1370-2026 Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit
Creator: Medica Corporation
Published: 2025-12-31
License: https://open.fda.gov/license/

Medica Corp. / initiated 2025-12-31 / Open, Classified / root cause: manufacturing process

FDA source

Medica Corporation began a recall of Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit on 2025-12-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1370-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-31
Posted: 2026-02-13
Recalling firm: Medica Corp.
Product: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1,578 units
Distribution: International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Product codes and lots: Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13

Product code CEM

K021515Class IIEasystat Ph, Pco2, Po2, Hct, Na+, K+, Ca++ AnalyzerMedica Corp. / cleared 2002-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)