Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
FDA device recall Z-1370-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Medica Corporation
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CEM
- Quantity affected
- 1,578 units
- Distribution
- International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
- Date initiated
- 2025-12-31
- Date posted
- 2026-02-13
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER (K021515) | Medica Corp. | 2002-07-16 |