Device recall
Z-0921-2018: ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0921-2018 |
|---|---|
| Recall event | 78838 |
| Product | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2019 |
| 510(k) numbers | K980367 |
| FEI number | 1628664 |
At a glance
- 1–9 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