Device recall
Z-1580-2020: LN 3R70-01; software version 2.6.2 and earlier. The software is used with the…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-1580-2020 |
|---|---|
| Recall event | 84831 |
| Product | LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. |
| Product code | JJE |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| 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