Oslo, NO · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | Class II | Hematology | 1 | 2023-09-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-06-17 | Class II | Ongoing | Z-2736-2024 | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | — | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived… |
| 2020-03-23 | Class II | Ongoing | Z-2192-2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 111… | — | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-… |