Device recall
Z-2797-2011: Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-2797-2011 |
|---|---|
| Recall event | 58916 |
| Product | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number… |
| Product code | GGK |
| Recalling firm | Sysmex America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2011 |
| FEI number | 1000515253 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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