Device recall
Z-0100-2014: pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8…
FDA device recall · Class II · Sysmex America Inc
Key facts
| Recall number (Z-number) | Z-0100-2014 |
|---|---|
| Recall event | 65722 |
| Product | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an… |
| Product code | GKZ |
| Recalling firm | Sysmex America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K032677 |
| FEI number | 3009711478 |
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