Device recall
Z-0789-2019: Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-0789-2019 |
|---|---|
| Recall event | 81916 |
| Product | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using… |
| Product code | JJE |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2022 |
| 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