Suzhou, CN · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | Class II | Immunology | 1 | 2023-08-02 |
| JGS | Electrode, Ion Specific, Sodium | Class II | Clinical Chemistry | 1 | 2023-07-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-01-10 | Class II | Ongoing | Z-1233-2025 | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. | — | Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays… |