Device recall
Z-0680-2024: Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0680-2024 |
|---|---|
| Recall event | 93355 |
| Product | Alinity i Processing Module REF 03R65-01 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 chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3016438761 |
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