Device recall
Z-1786-2010: directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
FDA device recall · Class II · International Technidyne Corporation
Key facts
| Recall number (Z-number) | Z-1786-2010 |
|---|---|
| Recall event | 55404 |
| Product | directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems. |
| Product code | GGN |
| Recalling firm | International Technidyne Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2010 |
| 510(k) numbers | K944691 |
| FEI number | 2250033 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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