Lisnamuck, IE · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CFR | Hexokinase, Glucose | Class II | Clinical Chemistry | 1 | 2025-10-24 |
| CJY | — | — | — | 1 | 2025-02-10 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-04-24 | Class III | Ongoing | Z-1696-2023 | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 | — | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the In… |