FDA Medical Device Recalls (openFDA)
Medica Corporation: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Recall number
- Z-1370-2026
- Recalling firm
- Medica Corporation
- Product
- Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Status
- Open, Classified
- Initiated
- 2025-12-31
- Posted
- 2026-02-13
- Terminated
- not on file
- 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.
- 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
- 1,578 units
- Distribution
- International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
- Lot, serial or model codes
- Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
- 510(k) numbers
- ["K021515"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 1220972
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28