Device recall
Z-1316-2019: Abbott Alinity ci-series System Control Module software version 2.5.1; LN…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-1316-2019 |
|---|---|
| Recall event | 82475 |
| Product | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01)… |
| Product code | JJE |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2025 |
| FEI number | 3002809144 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database