Ängelholm, SE · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GKR | System, Hemoglobin, Automated | Class II | Hematology | 1 | 2020-08-04 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-05-12 | Class II | Ongoing | Z-2070-2025 | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con… | — | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2020-08-04 | K201217 | HemoCue Hb 301 System | GKR | Class II | Hematology |