Bedford, MA, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CGA | — | — | — | 1 | 2024-07-26 |
| CEM | Electrode, Ion Specific, Potassium | Class II | Clinical Chemistry | 1 | 2023-09-26 |
| CHL | — | — | — | 1 | 2023-01-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-12-31 | Class II | Ongoing | Z-1370-2026 | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. | — | 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… |