Device recall
Z-2015-2011: CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2015-2011 |
|---|---|
| Recall event | 58188 |
| Product | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories. |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2011 |
| 510(k) numbers | K991605 |
| FEI number | 2919069 |
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