Device recall
Z-1522-2016: CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1522-2016 |
|---|---|
| Recall event | 73655 |
| Product | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an… |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2017 |
| 510(k) numbers | K081495 |
| 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