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U.S. Department of Health and Human Services

Class 2 Device Recall Medica Capillary Tubes

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 Class 2 Device Recall Medica Capillary Tubessee related information
Date Initiated by FirmDecember 31, 2025
Date PostedFebruary 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1370-2026
Recall Event ID 98315
510(K)NumberK021515 
Product Classification Electrode, ion specific, potassium - Product Code CEM
ProductMedica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Code Information Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
FEI Number 1220972
Recalling Firm/
Manufacturer		 Medica Corporation
5 Oak Park Dr
Bedford MA 01730-1430
For Additional Information ContactDavid Hagopian
781-5417402
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn 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 Commerce1,578 units
DistributionInternational distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CEM
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