Device recall
Z-1497-2019: Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo…
FDA device recall · Class II · Abbott Gmbh & Co. KG
Key facts
| Recall number (Z-number) | Z-1497-2019 |
|---|---|
| Recall event | 82595 |
| Product | Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as… |
| Product code | JJE |
| Recalling firm | Abbott Gmbh & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 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