Device recall
Z-0256-2013: Sysmex XE-2100C Automated Hematology System; an automated differential cell…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-0256-2013 |
|---|---|
| Recall event | 62580 |
| Product | Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening… |
| Product code | GKZ |
| Recalling firm | Sysmex America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2016 |
| 510(k) numbers | K051457 |
| FEI number | 1000515253 |
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